Quality Assurance Manager jobs at Adaptimmune - 252 jobs
Sr Manager, Design Quality Assurance - Continuous Improvement (Hybrid)
Insulet 4.7
San Diego, CA jobs
The Sr. Manager, Design Quality Assurance - Continuous Improvement, is responsible for leading strategic and results-driven Continuous Improvement initiatives that enhance efficiency, compliance, and innovation across our medical device design and development processes. This role will focus on driving process improvements while aligning with industry standards and collaborating with enterprise and cross-functional teams to optimize quality systems and product development workflows. In addition, focus on integrating best practices for the Software Development Life Cycle (SDLC) and accelerating efficient execution to enable faster time to market while maintaining compliance with global regulatory standards.
If you're a quality-focused leader with a passion for continuous improvement and cross-functional collaboration with medical industry experience, this opportunity is for you to drive innovative, efficient and compliant processes.
Responsibilities:
Drive and implement continuous improvement initiatives to optimize product development processes in partnership with cross-functional process owners.
Evaluate and optimize processes to ensure compliance with FDA, ISO 13485, ISO 14971, IEC 62304, and other regulatory standards.
Collaborate with internal standards teams to interpret and implement evolving industry and regulatory standards.
Partner with enterprise and cross-functional teams (R&D, Systems, Regulatory, Quality, Manufacturing, IT) to help drive systems/tools improvement initiatives and help resolve process inefficiencies.
Develop and track key performance indicators (KPIs) to measure the impact and sustainability of improvement initiatives.
Lead change management and training efforts to embed a culture of continuous improvement across the organization.
Support audit and inspection readiness by ensuring robust documentation and traceability of process improvements.
Lead and/or provide robust support for CAPAs as quality partners, ensuring timely investigations, root cause analysis, and effective implementation of corrective actions.
Benchmark internal processes against industry best practices and recommend enhancements.
Champion digital transformation opportunities within design quality systems.
Introduce and implement the best practices for the Software Development Life Cycle (SDLC), including requirements management, design verification, software risk management, and configuration control.
Collaborate with software engineering and quality teams to ensure alignment with IEC 62304 and other relevant software standards.
Drive initiatives that reduce development cycle times and improve execution efficiency without compromising quality or compliance.
Promote a proactive quality culture that supports innovation and accelerates time to market for new products.
Education and Experience:
Bachelor's degree in engineering, Life Sciences, or related field (master's preferred)
8+ years of experience in the medical device industry, with strong knowledge of design controls and quality systems.
Proven track record in leading cross-functional continuous improvement projects.
Deep understanding of regulatory standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, etc.).
Experience implementing SDLC best practices in regulated environments.
Lean Six Sigma certification (Green Belt or higher) preferred.
Excellent communication, leadership, program management and stakeholder management skills.
Skills/Competencies:
Effective verbal and written communication skills.
Experience collaborating and communicating with individuals at multiple levels in an organization.
Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
Conflict resolution skills including persuasive management techniques required.
Strong analytical and problem-solving skills.
Able to work effectively in a high-stress, high-energy environment.
Ability to influence people and projects in a fast-moving environment.
NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week. #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $150,300.00 - $225,450.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
(Know Your Rights)
$150.3k-225.5k yearly Auto-Apply 60d+ ago
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Director, GMP Quality Assurance
Disc Medicine 3.7
Massachusetts jobs
Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
POSITION OVERVIEW:
Disc Medicine is hiring a new Director, GMP Quality Assurance Biologics due to the fast growth of the company's portfolio. The successful candidate will serve as the primary Quality Assurance representative for Disc Medicine's Biologics pipeline including combination product development, manufacturing and disposition. This role will provide strategic and hands-on QA oversight for Disc Medicine's late-stage clinical trials via support of technology and method transfer, clinical manufacturing and batch disposition. Reporting to the Executive Director, GMP Quality Assurance, Biologics, this position will have broad exposure within Quality and CMC teams providing cross-functional experience in leading initiatives and processes with meaningful opportunities for professional development and career growth.
RESPONSIBILITIES:
Provide quality partnership and oversight of Disc Medicine's Biologics manufacturing, testing and disposition of products (Biologics) and combination products (Biologic + Device) processes. Experience with prefilled syringes (PFS) and safety device assembly is required.
Support ongoing technology transfer of drug product and device manufacturing processes and analytical methods to Disc Medicine's external CDMO's, including ensuring late-stage GMP requirements to support pivotal clinical trials.
Ensure compliance in Disc Medicine Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations: FDA (21 CFR Parts 4, 210, 211, 820), EU Eudralex GMP, including Annex 1 as well as ICH Guidance and applicable ISO 13485 Standards, FDA Quality Management System Regulation (QMSR), MDR 2017/745, Medical Device Regulation. Experience with Japanese regulatory requirements beneficial.
Collaborate with cross-functional teams to draft, review and verify documents to Health Authority CMC submissions for assigned projects and products including verification of documents, records, protocols, reports, and data.
Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of Disc Medicine combination products including deviations, investigations, change controls and CAPA both internally and externally.
Partner closely with internal stakeholders of Drug Product Manufacturing, Analytical Testing, Quality Control, Regulatory CMC, Clinical Operations and Supply Chain to ensure program alignment and timely delivery of quality milestones.
Identify and escalate quality risks while driving effective, compliant resolutions while fostering the development and refinement of a quality culture in a fast-paced, matrixed environment.
REQUIREMENTS:
Bachelor's Degree in a scientific discipline or related scientific field.
Years of Experience: 12-15 years of progressive Quality Assurance experience, with experience in Technology Transfer, Global Quality Management System design and implementation and experience in managing combination products (prefilled syringes required).
Hands on expertise with Combination Products (Device and Biologic) including the ability to develop business and QMS processes, procedures that guide manufacturing, QC testing, and supply chain from an operational and quality perspective.
Proven track record for building Quality culture with direct experience in supporting GMP operations; including but not limited to quality agreement negotiations, vendor management, complex investigations, GMP change management, and inspection readiness.
Proven track record for working on CMC, development program, quality management review, and vendor joint steering committees is required.
Demonstrated experience in all aspects of clinical development of biologics is desirable (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3 and Licensure); development of quality strategy and direct discussions with the applicable Health Authorities are key expectations and requirements of the position.
Candidates should be self-driven, extraordinarily organized, and have an established track record for building effective working relationships across a range of stakeholder groups.
Candidates should have the ability to convey complex issues, risks, solutions, and decisions succinctly
Ability to travel nationally and internationally (10-20%)
The annual base salary range for this position is listed below. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and internal parity.
Salary Range$193,800-$262,200 USD
Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.
$193.8k-262.2k yearly Auto-Apply 20d ago
Manager, Quality and Manufacturing
Hello Heart 3.9
Remote
Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information.
About the Role:
As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production.
Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes.
Responsibilities
Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation
Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones
Create and maintain quality control plans across IQC, IPQC, and OQC processes
Define and implement manufacturing process controls, test requirements, and build validation plan
Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies
Drive corrective and preventive actions and verify long-term effectiveness
Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health
Monitor yields, reduce defects, and drive continuous improvement across production lines
Assess supplier capability and lead onsite production reviews and factory evaluations
Define incoming inspection criteria, sampling plans, and supplier quality alignment
Maintain detailed build documentation, quality dashboards, and audit reports
Qualifications
7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline
Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes
Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma
Proven experience leading root cause analysis and driving corrective actions
Experience working with contract manufacturers and suppliers, preferably in Asia
Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data
Excellent communication skills with the ability to present findings and recommendations
Experience supporting NPI builds and high-volume product ramp is preferred
Familiarity with reliability testing and environmental qualification is preferred
Knowledge of hardware system integration spanning mechanical and electrical components is preferred
Experience with DOE, process optimization, or Lean Manufacturing is preferred
Mandarin language proficiency is a plus
The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits.
Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.
$140k-160k yearly Auto-Apply 13d ago
Director of Quality
Radiology Associates of North Texas 4.2
Fort Worth, TX jobs
We are seeking a highly motivated Director of Quality to lead and manage all quality initiatives across our organization. This role ensures compliance with regulatory standards, drives continuous improvement, and supports physician performance programs aligned with corporate goals.
Key Responsibilities
Develop and oversee quality programs and initiatives across the practice in conjunction with the RANT Quality Committee and senior leadership
Manages the Center for Medicare & Medicaid Services (CMS) Merit-Based Payment Program (MIPS) and maintains a high level of performance on Quality measures, Improvement Activities and Cost
Creates strategic planning initiatives to prepare for future demands of the CMS MIPS and MIPS Value Pathway programs
Coordinates with RANT's billing company to manage coding compliance with MIPS requirements to assure a high level of performance for the group and individual clinicians
Responsible for the management of corporate Quality policies and procedures to ensure alignment with mandated bodies like the U.S. Food and Drug Administration (FDA), Texas Department of State Health (DSHS), and CMS
Coordinate and provide support to Mammography imaging partners and physicians to assure compliance with FDA and Mammography Quality Standards Act (MQSA) requirements. Including the Mammography certification program
Manage physician performance improvement programs, including Ongoing Professional Practice Evaluation (OPPE), Focused Professional Practice Evaluation (FPPE) and inquiries related to provider performance
Manages the peer learning and peer review processes to maintain confidentiality and privilege while meeting the regulatory requirements for accreditation
Collaborate with Operations to develop facility metric reporting and implement ongoing quality-related audits
Prepare and presents Quality focused presentations to the Board of Directors, Medical Directors, physician group meetings and imaging partners
Collaborates with physicians and clients to assure compliance with hospital/clinic regulatory bodies and accreditation/designation to include the American College of Radiology, Stroke Designation, Hospital Trauma Centers, Neonatal Designation and MQSA
Ensure compliance with HIPAA, HITECH, MIPPA, and other regulatory requirements
Develops and provides quality education and training for staff and physicians
Leads and coordinates quality initiatives for the Quality and Safety Committee to include initiatives that adhere to Radiology best practices
Participates in projects in coordination with Patient Safety Organizations to improve the quality of care provided to our patients
Qualifications:
Masters Degree highly preferred in Radiologic Science, Healthcare Administration, or related field
Minimum 5 years of experience in a healthcare environment
Minimum 2 years experience leading a team
Certified Professional in Healthcare Quality (CPHQ) or willingness to obtain.
Strong knowledge of regulatory compliance and quality assurance principles
Excellent organizational and communication skills
Why Join Us?
Competitive compensation and benefits including robust retirement contribution
100% employer paid medical insurance plus monthly contributions to health savings account
Paid parental leave
Opportunity to lead quality initiatives in a nationally recognized radiology practice
Collaborative and innovative work environment
Hybrid work schedule (one work at home day weekly), with ability to work a 9/80 schedule
$108k-130k yearly est. 12d ago
QA Test Manager
Maximus, Inc. 4.3
Remote
Description & Requirements We are looking for a skilled QA Test Manager to lead our software quality assurance efforts and ensure the delivery of high-performing, reliable solutions. In this role, you will manage a team of QA engineers and testers, define and implement test strategies, and oversee both manual and automated testing processes. You will collaborate closely with development, product, and operations teams to integrate testing into the software development lifecycle and maintain the highest standards of quality.
* This is a fully remote position with 10% travel. *
Why Maximus?
* Competitive Compensation - Quarterly bonuses based on performance included!
* ️ Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance.
* Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching.
* ️ Paid Time Off Package - Enjoy UTO, Holidays, and sick leave, along with Short and Long Term Disability coverage.
* Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP).
* Recognition Platform - Acknowledge and appreciate outstanding employee contributions.
* Tuition Reimbursement - Invest in your ongoing education and development.
* Employee Perks and Discounts - Additional benefits and discounts exclusively for employees.
* Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs.
* Professional Development Opportunities- Participate in training programs, workshops, and conferences.
Essential Duties and Responsibilities:
* Accountable to ensure that the test team has full understanding of the business requirements and have the required information to begin initial test preparations.
* Participate in the business requirements reviews and anomaly reporting and tracking through closure.
* Accountable for thorough review and understanding of the business requirements by the test team and the test scenario definition begins.
* Provide guidance and training on the requirements elicitation process to the test team.
* Accountable to ensure that the test team is actively engaged in the analysis phase and fully understands the existing and future solution(s).
* Accountable for the creation of test scenarios that support the solution(s) and that those test scenarios provide adequate product coverage. Accountable for active test team participation in project peer reviews and /or test artifact peer reviews to ensure that test methodologies are followed and the test scenario content supports the scoped changes.
* Work with the PM to plan and prioritize release scope.
* Provide guidance and training on the requirements management and test preparation process to the test team.
* Accountable for thorough test team reviews of requirement changes and accurate updates to the supporting test scenarios based on requirement changes.
* Accountable for the adherence to change management procedures for the test scenarios.
* Accountable for active test team collaboration with the project team to ensure that the design specifications and the test scenarios support each other.
* Accountable for accurate test cases that support the solution(s) and maintain a high level of product coverage.
* Accountable to ensure that the test team is using MMS practices and tools.
* Accountable for a thorough initial review of test cases prior to project stakeholder review.
* Work with the project team to clarify use cases and/or requirements and acceptance criteria.
* Accountable for the active test team participation of test artifact peer reviews and processing anomalies to closure.
* Accountable for thorough test readiness reviews.
* Provide guidance and training on the technical design, test scenario, and test case methodology to the test team(s)
* Accountable for active test team participation in project peer reviews to ensure that test artifacts support the scoped changes.
* Accountable for the completion of test artifact peer reviews and finalized test cases for the software defects and enhancements.
* Accountable for completed anomalies.
* Work with the project team to prepare data sets and pre- requisites for the test cases. Accountable for on time data prep and complete pre-requisites.
* Accountable for completed test readiness reviews and completed action items.
* Assign test tasks and execute assigned test cases and log issues and defects.
* Provide test status and escalate issues to management.
* Accountable for complete, detailed, and accurate JIRAs.
* Provide guidance and training on the processes of development practices as related to the test environment, test execution, issue management and status reporting to the test team(s).
* Accountable for effective issue triage sessions to evaluate against existing functionality and determine outcome and priority.
* Accountable for test Team participation with Production Support.
* Provide guidance and training on effective issue management, severity and priority criteria, and test execution to the test team(s).
* Accountable for appropriate level of test resource participation with back end configuration changes or data preparation and any production support activities.
* Provide resource management, environment configuration requests and production support guidelines to the test teams and project teams.
* Accountable for proactive risk and issue identification, communication and tracking.
* Provide guidance and training for risk management, communication and issue tracking to the test team(s).
* Accountable for accurate reporting of test Team capacity, allocation and status to the PM and take action where appropriate.
* Accountable for accurate estimates and actual hours based on the project procedures.
* Accountable for team updates to JIRAs.
* Responsible for accurate requirements traceability throughout the release cycle.
* Provide guidance and training to the test teams on status reporting, total time accounting, estimation model, JIRA maintenance and traceability.
* Accountable for team compliance to the MAXIMUS standards and procedures.
* Responsible for adhering to established safety standards.
* Must be able to remain in a stationary position for an extended period of time.
* Occasionally lifts, carries, or otherwise moves items weighing up to 25 pounds.
* Work is constantly performed in an office environment.
* Perform other duties as necessary and assigned.
* Lead, mentor, and grow a team of software testers and QA engineers.
* Allocate resources effectively across projects and manage workload distribution.
* Foster a culture of continuous improvement and collaboration.
* Define and implement comprehensive test plans, test cases, and automation frameworks.
* Oversee manual and automated testing processes to ensure coverage and efficiency.
* Develop and enforce QA standards, best practices, documentation and metrics.
* Collaborate with development, product, and operations teams to integrate testing into the software development lifecycle
Minimum Requirements
* Bachelor's degree and 7-10 years of relevant experience or equivalent combination of education and experience required.
* Manages activities of two or more sections or departments.
* Exercises supervision in terms of costs, methods, and staffing.
* In some instances this manager may have subordinate supervisors and/or managers.
* Works on issues where analysis of situations or data requires an in- depth knowledge of organizational objectives.
* Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
* Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
* Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
* Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
* Establishes operational objectives and work plans and delegates assignments to subordinates.
* Senior management reviews objectives to determine success of operation.
* Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.
Program Specific Requirements:
* 5+ years of experience in software testing/QA, with at least 3 years in a leadership role - Required
* Strong knowledge of testing methodologies (unit, integration, system, regression, performance) - Required
* Hands-on experience with automation tools (JMeter and others) - Required
* Familiarity with CI/CD pipelines and DevOps practices - Required
* Expertise in Jira, Xray and Jama - Required
* Experience with cloud-based applications and microservices architecture. - Required
* Knowledge of Agile/Scrum methodologies. - Required
* Ability to manage multiple projects simultaneously in a fast-paced environment - Required
#HumanServices #LI-Remote #max Priority
EEO Statement
Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics.
Pay Transparency
Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances.
Accommodations
Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************.
$67k-110k yearly est. Easy Apply 14d ago
Quality Assurance Manager
Maximus 4.3
Columbus, OH jobs
Description & Requirements Maximus is currently hiring for a Quality AssuranceManager to support our Missouri Enrollment Broker project. This is a full time remote opportunity. The Quality Manager is responsible for overseeing the daily operations for the Quality Assurance team, and for creating efficient business partnerships to meet business goals. The project will be a multi-channel contact center that will support multiple clients throughout the state of Missouri.
*This job is contingent upon contract award.*
At Maximus we offer a wide range of benefits to include:
- • Competitive Compensation - Quarterly bonuses based on performance included!
- • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance.
- • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching.
- • Unlimited Time Off Package - Enjoy UTO, Holidays, and sick leave,
- • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP).
- • Recognition Platform - Acknowledge and appreciate outstanding employee contributions.
- • Tuition Reimbursement - Invest in your ongoing education and development.
- • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees.
- • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs.
- • Professional Development Opportunities- Participate in training programs, workshops, and conferences.
Essential Duties and Responsibilities:
- Oversee the day-to-day functions of the Quality Assurance (QA) department.
- Manage an effective quality assurance program that monitors and resolves issues before they become problems.
- Supervise the development and regular update of policies and procedures.
- Evaluate the need for and ensure the provision of necessary training for project personnel, providing up-to-date information on relevant programs, community resources, and options for consumers.
- Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements.
- Provide project leadership with updates on all issues regarding quality, operations, training, and policy and procedures.
- Provide leadership to all staff in the areas of quality improvement as it relates to process improvement, customer service and conflict resolution.
- Prepare reports and briefings for project leadership and review monthly and quarterly project status reports provided to the Department.
Minimum Requirements
- Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience.
- Must be willing and able to travel up to 25% of the time as business need dictates.
- Lean Six Sigma experience with a minimum of Yellow Belt Certification required.
- Experience managing direct reports remotely required.
- Experience with designing, implementing and reporting customer satisfaction surveys required.
- Experience with standardized quality tools required.
- Experience with call and voice monitoring platforms required.
- Experience with a large-scale telephony system required.
- Experience with Client Relationship Management (CRM) platforms required.
- Experience with contract compliance and quality platforms required.
- Experience with statistical processes required.
- Premium contact center billing experience required.
- Financial experience with Oracle preferred.
Home Office Requirements:
- Internet speed of 20mbps or higher required (you can test this by going to *******************
- Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router.
- Must currently and permanently reside in the Continental US.
#max Priority
EEO Statement
Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics.
Pay Transparency
Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances.
Accommodations
Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************.
Minimum Salary
$
80,000.00
Maximum Salary
$
95,000.00
$69k-98k yearly est. Easy Apply 5d ago
Quality Manager
Heart of Ohio Family Hea Lth Centers 3.0
Columbus, OH jobs
The primary function of the Quality Program Manager is responsible for providing day to day management of the quality improvement program. Responsible for coordinating activities of quality department staff, suggesting process changes, measuring data, and completing QA activities to achieve organization goals for quality measures for programs like UDS, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, CMC, and individual insurance plan contracts.
Reports to: Director of Quality and Clinical Systems
Supervises: Yes
Dress Requirement: Business Casual
Work Schedule:
Monday through Friday during standard business hours
Times are subject to change due to business necessity
Exempt
Essential Job Duties and Responsibilities
Work with supervisor and members of clinical leadership to develop, implement, monitor, and measure plans to improve processes and quality outcomes.
Work with supervisor, clinical leadership, data analytics team, and external data vendor Unity PHM to analyze data, clean data, and perform quality assurance activities.
In collaboration with supervisor, Chief Medical Officer, and others, the position is responsible for carrying out system-wide quality programs. Assists with developing, planning, and implementing policies and procedures.
Works closely with supervisors, clinical teams, and non-clinical teams for quality improvement efforts. Assists with designing processes for quality improvement purposes.
Plays a key role in maximizing revenue from value-based care, pay-for-performance, and risk adjustment contracts. Ensure compliances with program requirements. Examples include individual insurance plan contracts, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, and CMC programs.
Focuses on better healthcare value and quality, including the improvement of clinical outcomes, patient experience, patient safety, costs, revenue, productivity, efficiency, employee and physician satisfaction, and process reliability.
Leads or participates in meetings related to quality improvement.
Coordinate, manage and report UDS measures and other data related to clinical quality.
Manages performance improvement projects to assure milestones and key performance indicators are met within defined parameters. Documents the results of projects, and submits other documentation as requested.
Develop and motivate department staff. Interview, monitor time and attendance, and manage performance of subordinates.
Report on clinical quality measures internally and externally. Provide updates to internal and external stakeholders on progress in quality initiatives.
Support data collection and reporting related to grants.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
Qualifications
Education:
Bachelor's degree in a related field required. Examples include nursing, healthcare administration, public health, or similar.
Certifications such as CPHQ and Lean Six Sigma are beneficial, but not required.
Experience:
At least four years of experience in the healthcare field, quality, data analytics, and/or management strongly preferred. Master's level education and appropriate background may substitute for some experience.
Knowledge of clinical operations including the functions of the front and back-office utilization information systems is preferred.
Previous experience working in an outpatient clinic is preferred.
Knowledge/Abilities:
Excellent communication skills, both written and verbal, are required.
Strong organization and time management skills are required.
Ability to work independently and demonstrate initiative is required.
Proficiency with Microsoft Office is required.
Displays cheerful demeanor and makes positive comments when on duty.
Works cooperatively with other staff members.
Displays sensitivity in a multi-cultural environment.
General understanding of the medical billing process is preferred.
Equipment Operated :
Telephone
Computer
Printer
Fax machine
Copier
Other office equipment as assigned
Other office and medical equipment as assigned
Facility Environment :
Heart of Ohio Family Health operates in multiple locations, in Columbus, OH. All facilities have a medical office environment with front-desk reception area, separate patient examination rooms, nursing stations, pharmacy stock room, business offices, hallways and private toilet facilities. All facilities are ADA compliant.
The patient examination rooms and office area is:
kept at a normal working temperature
sanitized daily
maintains standard office environment furniture with adjustable chairs
maintains standard office equipment; i.e., computer, copier, fax machine, etc. at a normal working height
Physical Demands and Requirements : these may be modified to accurately perform the essential functions of the position:
Mobility = ability to easily move without assistance
Bending = occasional bending from the waist and knees
Reaching = occasional reaching no higher than normal arm stretch
Lifting/Carry = ability to lift and carry a normal stack of documents and/or files
Pushing/Pulling = ability to push or pull a normal office environment
Dexterity = ability to handle and/or grasp, use a keyboard, calculator, and other office equipment accurately and quickly
Hearing = ability to accurately hear and react to the normal tone of a person's voice
Visual = ability to safely and accurately see and react to factors and objects in a normal setting
Speaking = ability to pronounce words clearly to be understood by another individual
$69k-90k yearly est. Auto-Apply 60d+ ago
Quality Manager
Heart of Ohio Family Hea Lth Centers 3.0
Columbus, OH jobs
The primary function of the Quality Program Manager is responsible for providing day to day management of the quality improvement program. Responsible for coordinating activities of quality department staff, suggesting process changes, measuring data, and completing QA activities to achieve organization goals for quality measures for programs like UDS, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, CMC, and individual insurance plan contracts.
Reports to: Director of Quality and Clinical Systems
Supervises: Yes
Dress Requirement: Business Casual
Work Schedule:
Monday through Friday during standard business hours
Times are subject to change due to business necessity
Exempt
Essential Job Duties and Responsibilities
Work with supervisor and members of clinical leadership to develop, implement, monitor, and measure plans to improve processes and quality outcomes.
Work with supervisor, clinical leadership, data analytics team, and external data vendor Unity PHM to analyze data, clean data, and perform quality assurance activities.
In collaboration with supervisor, Chief Medical Officer, and others, the position is responsible for carrying out system-wide quality programs. Assists with developing, planning, and implementing policies and procedures.
Works closely with supervisors, clinical teams, and non-clinical teams for quality improvement efforts. Assists with designing processes for quality improvement purposes.
Plays a key role in maximizing revenue from value-based care, pay-for-performance, and risk adjustment contracts. Ensure compliances with program requirements. Examples include individual insurance plan contracts, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, and CMC programs.
Focuses on better healthcare value and quality, including the improvement of clinical outcomes, patient experience, patient safety, costs, revenue, productivity, efficiency, employee and physician satisfaction, and process reliability.
Leads or participates in meetings related to quality improvement.
Coordinate, manage and report UDS measures and other data related to clinical quality.
Manages performance improvement projects to assure milestones and key performance indicators are met within defined parameters. Documents the results of projects, and submits other documentation as requested.
Develop and motivate department staff. Interview, monitor time and attendance, and manage performance of subordinates.
Report on clinical quality measures internally and externally. Provide updates to internal and external stakeholders on progress in quality initiatives.
Support data collection and reporting related to grants.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
Qualifications
Education:
Bachelor's degree in a related field required. Examples include nursing, healthcare administration, public health, or similar.
Certifications such as CPHQ and Lean Six Sigma are beneficial, but not required.
Experience:
At least four years of experience in the healthcare field, quality, data analytics, and/or management strongly preferred. Master's level education and appropriate background may substitute for some experience.
Knowledge of clinical operations including the functions of the front and back-office utilization information systems is preferred.
Previous experience working in an outpatient clinic is preferred.
Knowledge/Abilities:
Excellent communication skills, both written and verbal, are required.
Strong organization and time management skills are required.
Ability to work independently and demonstrate initiative is required.
Proficiency with Microsoft Office is required.
Displays cheerful demeanor and makes positive comments when on duty.
Works cooperatively with other staff members.
Displays sensitivity in a multi-cultural environment.
General understanding of the medical billing process is preferred.
Equipment Operated:
Telephone
Computer
Printer
Fax machine
Copier
Other office equipment as assigned
Other office and medical equipment as assigned
Facility Environment:
Heart of Ohio Family Health operates in multiple locations, in Columbus, OH. All facilities have a medical office environment with front-desk reception area, separate patient examination rooms, nursing stations, pharmacy stock room, business offices, hallways and private toilet facilities. All facilities are ADA compliant.
The patient examination rooms and office area is:
kept at a normal working temperature
sanitized daily
maintains standard office environment furniture with adjustable chairs
maintains standard office equipment; i.e., computer, copier, fax machine, etc. at a normal working height
Physical Demands and Requirements: these may be modified to accurately perform the essential functions of the position:
Mobility = ability to easily move without assistance
Bending = occasional bending from the waist and knees
Reaching = occasional reaching no higher than normal arm stretch
Lifting/Carry = ability to lift and carry a normal stack of documents and/or files
Pushing/Pulling = ability to push or pull a normal office environment
Dexterity = ability to handle and/or grasp, use a keyboard, calculator, and other office equipment accurately and quickly
Hearing = ability to accurately hear and react to the normal tone of a person's voice
Visual = ability to safely and accurately see and react to factors and objects in a normal setting
Speaking = ability to pronounce words clearly to be understood by another individual
$69k-90k yearly est. Auto-Apply 60d+ ago
Quality Manager
Heart of Ohio Family Health 3.0
Columbus, OH jobs
The primary function of the Quality Program Manager is responsible for providing day to day management of the quality improvement program. Responsible for coordinating activities of quality department staff, suggesting process changes, measuring data, and completing QA activities to achieve organization goals for quality measures for programs like UDS, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, CMC, and individual insurance plan contracts.
Reports to: Director of Quality and Clinical Systems
Supervises: Yes
Dress Requirement: Business Casual
Work Schedule:
Monday through Friday during standard business hours
Times are subject to change due to business necessity
Exempt
Essential Job Duties and Responsibilities
* Work with supervisor and members of clinical leadership to develop, implement, monitor, and measure plans to improve processes and quality outcomes.
* Work with supervisor, clinical leadership, data analytics team, and external data vendor Unity PHM to analyze data, clean data, and perform quality assurance activities.
* In collaboration with supervisor, Chief Medical Officer, and others, the position is responsible for carrying out system-wide quality programs. Assists with developing, planning, and implementing policies and procedures.
* Works closely with supervisors, clinical teams, and non-clinical teams for quality improvement efforts. Assists with designing processes for quality improvement purposes.
* Plays a key role in maximizing revenue from value-based care, pay-for-performance, and risk adjustment contracts. Ensure compliances with program requirements. Examples include individual insurance plan contracts, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, and CMC programs.
* Focuses on better healthcare value and quality, including the improvement of clinical outcomes, patient experience, patient safety, costs, revenue, productivity, efficiency, employee and physician satisfaction, and process reliability.
* Leads or participates in meetings related to quality improvement.
* Coordinate, manage and report UDS measures and other data related to clinical quality.
* Manages performance improvement projects to assure milestones and key performance indicators are met within defined parameters. Documents the results of projects, and submits other documentation as requested.
* Develop and motivate department staff. Interview, monitor time and attendance, and manage performance of subordinates.
* Report on clinical quality measures internally and externally. Provide updates to internal and external stakeholders on progress in quality initiatives.
* Support data collection and reporting related to grants.
* This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
Qualifications
Education:
* Bachelor's degree in a related field required. Examples include nursing, healthcare administration, public health, or similar.
* Certifications such as CPHQ and Lean Six Sigma are beneficial, but not required.
Experience:
* At least four years of experience in the healthcare field, quality, data analytics, and/or management strongly preferred. Master's level education and appropriate background may substitute for some experience.
* Knowledge of clinical operations including the functions of the front and back-office utilization information systems is preferred.
* Previous experience working in an outpatient clinic is preferred.
Knowledge/Abilities:
* Excellent communication skills, both written and verbal, are required.
* Strong organization and time management skills are required.
* Ability to work independently and demonstrate initiative is required.
* Proficiency with Microsoft Office is required.
* Displays cheerful demeanor and makes positive comments when on duty.
* Works cooperatively with other staff members.
* Displays sensitivity in a multi-cultural environment.
* General understanding of the medical billing process is preferred.
Equipment Operated:
Telephone
Computer
Printer
Fax machine
Copier
Other office equipment as assigned
Other office and medical equipment as assigned
Facility Environment:
Heart of Ohio Family Health operates in multiple locations, in Columbus, OH. All facilities have a medical office environment with front-desk reception area, separate patient examination rooms, nursing stations, pharmacy stock room, business offices, hallways and private toilet facilities. All facilities are ADA compliant.
The patient examination rooms and office area is:
* kept at a normal working temperature
* sanitized daily
* maintains standard office environment furniture with adjustable chairs
* maintains standard office equipment; i.e., computer, copier, fax machine, etc. at a normal working height
Physical Demands and Requirements: these may be modified to accurately perform the essential functions of the position:
* Mobility = ability to easily move without assistance
* Bending = occasional bending from the waist and knees
* Reaching = occasional reaching no higher than normal arm stretch
* Lifting/Carry = ability to lift and carry a normal stack of documents and/or files
* Pushing/Pulling = ability to push or pull a normal office environment
* Dexterity = ability to handle and/or grasp, use a keyboard, calculator, and other office equipment accurately and quickly
* Hearing = ability to accurately hear and react to the normal tone of a person's voice
* Visual = ability to safely and accurately see and react to factors and objects in a normal setting
* Speaking = ability to pronounce words clearly to be understood by another individual
$69k-90k yearly est. 60d+ ago
Quality Assurance Manager
GE Healthcare 4.8
Cleveland, OH jobs
This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM to give patients more precise, personalized care.
****************************
The QA Manager is a versatile and dynamic member of the Quality team. The QA Manager will support the CAPA system, Complaint Management and Document Control activities to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. They will also keep up to date with the requirements of the industry and develop a deep understanding of company processes to build a robust and efficient QMS to support the business. The QA Manager is responsible for adherence to the MIM Software Quality System.
As a critical member of the team, you will ensure adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness, and the commercial delivery of MIM Software/ GE HealthCare systems.
**Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.**
**Job Description**
**What You'll Do:**
+ Ensure QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc meet all applicable quality & regulatory standards.
+ Write, update, and review quality documents, procedures, policies and business processes ensuring on-going compliance with current regulations, standards and applicable certifications.
+ Assist and lead in investigating nonconformities and use appropriate tools to determine the root cause.
+ Develop product knowledge to make informed decisions that influence product quality and safety.
+ Support audits by promptly delivering complete and accurate records.
+ Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes.
+ Implement improvements to drive compliance, quality, and efficiency of these processes.
+ Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.
+ Assist during audits in the room (supplier, critical supplier, notified body, or otherwise)
+ Proficient knowledge of MIM's product portfolios and Primary Products and classifications.
+ Stay current with the latest guidance documents, regulatory requirements, and industry best practices.
+ Assist in other areas of the QMS as directed by the manager.
**What You'll Need:**
+ Bachelor's degree from an accredited university or college.
+ At least 7 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD)
+ Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to FDA CFR 21 820, ISO 13485, and MDSAP.
+ Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.
+ Demonstrated experience in leading and managing a team effectively.
+ Demonstrated ability to collaborate effectively and resolve conflicts.
**Desired Characteristics:**
+ Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering or Manufacturing Engineering in the Medical Device field.
+ Demonstrated expertise in root cause analysis.
+ Strong influencing skills and ability to clearly communicate the requirements to cross-functional teams.
+ Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
+ Proficiency in managing multiple priorities effectively.
+ Thrives in a dynamic environment and is comfortable navigating change
+ Takes initiative, manages time effectively, and is motivated to achieve goals without constant oversight. You're proactive in identifying opportunities and solving problems independently.
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
**Additional Information**
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
**Relocation Assistance Provided:** No
$101k-127k yearly est. 60d+ ago
Quality Assurance Manager
GE Healthcare Technologies Inc. 4.2
Cleveland, OH jobs
This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM to give patients more precise, personalized care.
****************************
The QA Manager is a versatile and dynamic member of the Quality team. The QA Manager will support the CAPA system, Complaint Management and Document Control activities to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. They will also keep up to date with the requirements of the industry and develop a deep understanding of company processes to build a robust and efficient QMS to support the business. The QA Manager is responsible for adherence to the MIM Software Quality System.
As a critical member of the team, you will ensure adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness, and the commercial delivery of MIM Software/ GE HealthCare systems.
Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Job Description
What You'll Do:
* Ensure QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc meet all applicable quality & regulatory standards.
* Write, update, and review quality documents, procedures, policies and business processes ensuring on-going compliance with current regulations, standards and applicable certifications.
* Assist and lead in investigating nonconformities and use appropriate tools to determine the root cause.
* Develop product knowledge to make informed decisions that influence product quality and safety.
* Support audits by promptly delivering complete and accurate records.
* Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes.
* Implement improvements to drive compliance, quality, and efficiency of these processes.
* Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.
* Assist during audits in the room (supplier, critical supplier, notified body, or otherwise)
* Proficient knowledge of MIM's product portfolios and Primary Products and classifications.
* Stay current with the latest guidance documents, regulatory requirements, and industry best practices.
* Assist in other areas of the QMS as directed by the manager.
What You'll Need:
* Bachelor's degree from an accredited university or college.
* At least 7 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD)
* Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to FDA CFR 21 820, ISO 13485, and MDSAP.
* Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.
* Demonstrated experience in leading and managing a team effectively.
* Demonstrated ability to collaborate effectively and resolve conflicts.
Desired Characteristics:
* Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering or Manufacturing Engineering in the Medical Device field.
* Demonstrated expertise in root cause analysis.
* Strong influencing skills and ability to clearly communicate the requirements to cross-functional teams.
* Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
* Proficiency in managing multiple priorities effectively.
* Thrives in a dynamic environment and is comfortable navigating change
* Takes initiative, manages time effectively, and is motivated to achieve goals without constant oversight. You're proactive in identifying opportunities and solving problems independently.
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
$101k-127k yearly est. 7d ago
Quality Assurance Manager
GE Healthcare 4.8
Beachwood, OH jobs
This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM to give patients more precise, personalized care.
****************************
The QA Manager is a versatile and dynamic member of the Quality team. The QA Manager will support the CAPA system, Complaint Management and Document Control activities to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. They will also keep up to date with the requirements of the industry and develop a deep understanding of company processes to build a robust and efficient QMS to support the business. The QA Manager is responsible for adherence to the MIM Software Quality System.
As a critical member of the team, you will ensure adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness, and the commercial delivery of MIM Software/ GE HealthCare systems.
**Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.**Job Description
What You'll Do:
Ensure QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc meet all applicable quality & regulatory standards.
Write, update, and review quality documents, procedures, policies and business processes ensuring on-going compliance with current regulations, standards and applicable certifications.
Assist and lead in investigating nonconformities and use appropriate tools to determine the root cause.
Develop product knowledge to make informed decisions that influence product quality and safety.
Support audits by promptly delivering complete and accurate records.
Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes.
Implement improvements to drive compliance, quality, and efficiency of these processes.
Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.
Assist during audits in the room (supplier, critical supplier, notified body, or otherwise)
Proficient knowledge of MIM's product portfolios and Primary Products and classifications.
Stay current with the latest guidance documents, regulatory requirements, and industry best practices.
Assist in other areas of the QMS as directed by the manager.
What You'll Need:
Bachelor's degree from an accredited university or college.
At least 7 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD)
Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to FDA CFR 21 820, ISO 13485, and MDSAP.
Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.
Demonstrated experience in leading and managing a team effectively.
Demonstrated ability to collaborate effectively and resolve conflicts.
Desired Characteristics:
Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering or Manufacturing Engineering in the Medical Device field.
Demonstrated expertise in root cause analysis.
Strong influencing skills and ability to clearly communicate the requirements to cross-functional teams.
Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
Proficiency in managing multiple priorities effectively.
Thrives in a dynamic environment and is comfortable navigating change
Takes initiative, manages time effectively, and is motivated to achieve goals without constant oversight. You're proactive in identifying opportunities and solving problems independently.
We will not sponsor individuals for employment visas, now or in the future, for this job opening. Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
$101k-127k yearly est. Auto-Apply 60d+ ago
Patient Access Quality Assurance Coordinator
Ensemble Health Partners 4.0
Tyler, TX jobs
Thank you for considering a career at Ensemble Health Partners!
Ensemble Health Partners is a leading provider of technology-enabled revenue cycle management solutions for health systems, including hospitals and affiliated physician groups. They offer end-to-end revenue cycle solutions as well as a comprehensive suite of point solutions to clients across the country.
Ensemble keeps communities healthy by keeping hospitals healthy. We recognize that healthcare requires a human touch, and we believe that every touch should be meaningful. This is why our people are the most important part of who we are. By empowering them to challenge the status quo, we know they will be the difference!
O.N.E Purpose:
Customer Obsession: Consistently provide exceptional experiences for our clients, patients, and colleagues by understanding their needs and exceeding their expectations.
Embracing New Ideas: Continuously innovate by embracing emerging technology and fostering a culture of creativity and experimentation.
Striving for Excellence: Execute at a high level by demonstrating our “Best in KLAS” Ensemble Difference Principles and consistently delivering outstanding results.
The Opportunity:
***This position is an onsite role, and candidates must be able to work on-site at the hospital.****
The Opportunity:
With little supervision, the Patient Access Quality Assurance Specialist will work directly with all levels of Patient Access leadership and the individual Patient Access Specialists and Sr. Patient Access Specialists. They will be responsible for auditing Patient Access calls, accounts, and work queues to ensure compliance and consistency to policy and procedure. They will be responsible for identifying trends and provide reporting for training/coaching purposes to both leadership and associates. In addition to auditing accounts, the auditor will ensure monthly quality scorecards are completed accurately and adhere to department standards and established metrics for quality.
This position pays between $17.00 - $18.15/hr based on experience
Job Responsibilities:
The QA specialist will be responsible for auditing Patient Access calls, accounts, and work queues to ensure compliance and consistency to policy and procedure.
They will monitor the quality audit tool and process and ensures accurate record keeping and audit scoring and system documentation.
They will be responsible for identifying trends and recommend quality and training needs of the department.
The auditor will partner with the leadership team to monitor, record and provide individual performance reporting for training/coaching purposes.
They will ensure monthly quality scorecards are completed accurately and adhere to department standards and established metrics for quality.
They will be responsible to collaborate with Patient Access leadership to remain updated on any new policy and procedure changes to make necessary changes on all associate scorecards.
Continuous research, development and implementation of new quality procedures and programs to ensure cutting edge ideas and efficiencies.
They will be expected to provide routine calibrations with the associates to further explain the score.
They will be expected to provide ad hoc audits requested by Patient Access leadership, in addition to normal account edits.
Experience We Love:
• 1 - 3 years of customer service experience
Required Qualifications:
• High School Diploma/GED Required
• CRCR Required within 9 months of hire
Other Preferred Knowledge, Skills and Abilities
Other 4 year/ Bachelors Degree
Minimum Years and Type of Experience: 2 years of Patient Access operations experience
Other Knowledge, Skills and Abilities Required:
Knowledgeable in Patient Access Services and Patient Access technology, applications, systems, processes.
Knowledgeable in all Microsoft Office products, with an emphasis in Excel.
Join an award-winning company
Five-time winner of “Best in KLAS” 2020-2022, 2024-2025
Black Book Research's Top Revenue Cycle Management Outsourcing Solution 2021-2024
22 Healthcare Financial Management Association (HFMA) MAP Awards for High Performance in Revenue Cycle 2019-2024
Leader in Everest Group's RCM Operations PEAK Matrix Assessment 2024
Clarivate Healthcare Business Insights (HBI) Revenue Cycle Awards for strong performance 2020, 2022-2023
Energage Top Workplaces USA 2022-2024
Fortune Media Best Workplaces in Healthcare 2024
Monster Top Workplace for Remote Work 2024
Great Place to Work certified 2023-2024
Innovation
Work-Life Flexibility
Leadership
Purpose + Values
Bottom line, we believe in empowering people and giving them the tools and resources needed to thrive. A few of those include:
Associate Benefits - We offer a comprehensive benefits package designed to support the physical, emotional, and financial health of you and your family, including healthcare, time off, retirement, and well-being programs.
Our Culture - Ensemble is a place where associates can do their best work and be their best selves. We put people first, last and always. Our culture is rooted in collaboration, growth, and innovation.
Growth - We invest in your professional development. Each associate will earn a professional certification relevant to their field and can obtain tuition reimbursement.
Recognition - We offer quarterly and annual incentive programs for all employees who go beyond and keep raising the bar for themselves and the company.
Ensemble Health Partners is an equal employment opportunity employer. It is our policy not to discriminate against any applicant or employee based on race, color, sex, sexual orientation, gender, gender identity, religion, national origin, age, disability, military or veteran status, genetic information or any other basis protected by applicable federal, state, or local laws. Ensemble Health Partners also prohibits harassment of applicants or employees based on any of these protected categories.
Ensemble Health Partners provides reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law. If you require accommodation in the application process, please contact *****************.
This posting addresses state specific requirements to provide pay transparency. Compensation decisions consider many job-related factors, including but not limited to geographic location; knowledge; skills; relevant experience; education; licensure; internal equity; time in position. A candidate entry rate of pay does not typically fall at the minimum or maximum of the role's range.
EEOC - Know Your Rights
FMLA Rights - English
La FMLA Español
E-Verify Participating Employer (English and Spanish)
Know your Rights
$17-18.2 hourly Auto-Apply 24d ago
Sr. Specialist, QA
Biomarin Pharmaceutical Inc. 4.6
Novato, CA jobs
About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
SUMMARY
This position is responsible for preparing and performing Quality release for raw materials and product lots manufactured in Novato.
RESPONSIBILITIES
* Perform Inspection (when applicable), Review, and Disposition of incoming raw materials at the Novato GMP Warehouse(s)
* Maintain electronic status control and data entry in ERP system for GMP raw materials
* Quality review and revision of BioMarin Raw Material Specifications and Standard Operating Procedures using the Electronic Document Management System
* Perform visual inspection and release of primary packaging components. This includes but not limited to, managing coordination of samples with QCRM, and ensuring timely maintenance and calibration of inspection equipment.
* Provide QA support to other QA raw materials activities: Control of rejected materials, material return program, and other Warehouse QA responsibilities, as assigned
* Verify deviation closure in electronic QMS and QC sample results in LIMS.
* Prepare and assemble the production batch record lot files and supplemental files for FBDS/DP lot release.
* Responsible for the preparation of FBDS/DP documentation, including preparation of the Approval Checklist and Certificate of Compliance For Further Processing (CCFP).
* Stay current with Compliance Wire electronic training system.
* Other duties as assigned.
EXPERIENCE
Required Skills:
At least 2 years of directly related experience in a GMP Quality environment.
Proven comprehension of Quality functions and regulatory expectations of a GMP facility.
Understanding of GMP operations and processes as applicable to Quality Assurance Lot Release
Strong verbal and written communication skills.
Attention to detail when performing Quality release.
Desired Skills:
At least 2 to 5 years of directly related experience in a GMP Quality environment.
Experience with ERP and LIMS systems such as SAP and Labware LIMS (experience with Quality Management within ERP is a plus).
Experience and familiarity with Manufacturing Execution System (MES) are a plus.
EDUCATION
BA or BS in a technical discipline (physical or biological sciences preferred).
EQUIPMENT
This position does not utilize any specific equipment.
CONTACTS
This position will require interaction primarily with the Manager of QA Lot Release and other QA Associates and Sr. Specialists within the QA Lot Release team. This position may also interact with other departments and levels within Quality Assurance and Quality Control such as but not limited to the Quality Site Head, Director of Quality Assurance, Associates and Specialists within Quality Assurance Frontline, Associates and Technical Managers within Quality Assurance Operations, as well as Quality Control analysts and management.
SHIFT DETAILS
This position is expected to work from Monday to Friday at the standard day shift hours (9 am to 5 pm). This position may require work during off hours, holidays, and/or weekends, as needed to maintain critical business operations.
ONSITE, REMOTE, OR FLEXIBLE
This position is expected to be primarily onsite, however some remote work up to 2 days a week can be performed with approval of the QA Lot Release Manager.
TRAVEL REQUIRED
Travel is not a requirement for this position.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
The salary range for this position is: $68,900 to $94,710. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
$68.9k-94.7k yearly 55d ago
Quality Assurance Manager
Maximus 4.3
Cleveland, OH jobs
Description & Requirements Maximus is currently hiring for a Quality AssuranceManager to support our Missouri Enrollment Broker project. This is a full time remote opportunity. The Quality Manager is responsible for overseeing the daily operations for the Quality Assurance team, and for creating efficient business partnerships to meet business goals. The project will be a multi-channel contact center that will support multiple clients throughout the state of Missouri.
*This job is contingent upon contract award.*
At Maximus we offer a wide range of benefits to include:
- • Competitive Compensation - Quarterly bonuses based on performance included!
- • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance.
- • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching.
- • Unlimited Time Off Package - Enjoy UTO, Holidays, and sick leave,
- • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP).
- • Recognition Platform - Acknowledge and appreciate outstanding employee contributions.
- • Tuition Reimbursement - Invest in your ongoing education and development.
- • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees.
- • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs.
- • Professional Development Opportunities- Participate in training programs, workshops, and conferences.
Essential Duties and Responsibilities:
- Oversee the day-to-day functions of the Quality Assurance (QA) department.
- Manage an effective quality assurance program that monitors and resolves issues before they become problems.
- Supervise the development and regular update of policies and procedures.
- Evaluate the need for and ensure the provision of necessary training for project personnel, providing up-to-date information on relevant programs, community resources, and options for consumers.
- Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements.
- Provide project leadership with updates on all issues regarding quality, operations, training, and policy and procedures.
- Provide leadership to all staff in the areas of quality improvement as it relates to process improvement, customer service and conflict resolution.
- Prepare reports and briefings for project leadership and review monthly and quarterly project status reports provided to the Department.
Minimum Requirements
- Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience.
- Must be willing and able to travel up to 25% of the time as business need dictates.
- Lean Six Sigma experience with a minimum of Yellow Belt Certification required.
- Experience managing direct reports remotely required.
- Experience with designing, implementing and reporting customer satisfaction surveys required.
- Experience with standardized quality tools required.
- Experience with call and voice monitoring platforms required.
- Experience with a large-scale telephony system required.
- Experience with Client Relationship Management (CRM) platforms required.
- Experience with contract compliance and quality platforms required.
- Experience with statistical processes required.
- Premium contact center billing experience required.
- Financial experience with Oracle preferred.
Home Office Requirements:
- Internet speed of 20mbps or higher required (you can test this by going to *******************
- Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router.
- Must currently and permanently reside in the Continental US.
#max Priority
EEO Statement
Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics.
Pay Transparency
Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances.
Accommodations
Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************.
Minimum Salary
$
80,000.00
Maximum Salary
$
95,000.00
$71k-102k yearly est. Easy Apply 5d ago
Quality Assurance Manager
Maximus 4.3
Cincinnati, OH jobs
Description & Requirements Maximus is currently hiring for a Quality AssuranceManager to support our Missouri Enrollment Broker project. This is a full time remote opportunity. The Quality Manager is responsible for overseeing the daily operations for the Quality Assurance team, and for creating efficient business partnerships to meet business goals. The project will be a multi-channel contact center that will support multiple clients throughout the state of Missouri.
*This job is contingent upon contract award.*
At Maximus we offer a wide range of benefits to include:
- • Competitive Compensation - Quarterly bonuses based on performance included!
- • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance.
- • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching.
- • Unlimited Time Off Package - Enjoy UTO, Holidays, and sick leave,
- • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP).
- • Recognition Platform - Acknowledge and appreciate outstanding employee contributions.
- • Tuition Reimbursement - Invest in your ongoing education and development.
- • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees.
- • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs.
- • Professional Development Opportunities- Participate in training programs, workshops, and conferences.
Essential Duties and Responsibilities:
- Oversee the day-to-day functions of the Quality Assurance (QA) department.
- Manage an effective quality assurance program that monitors and resolves issues before they become problems.
- Supervise the development and regular update of policies and procedures.
- Evaluate the need for and ensure the provision of necessary training for project personnel, providing up-to-date information on relevant programs, community resources, and options for consumers.
- Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements.
- Provide project leadership with updates on all issues regarding quality, operations, training, and policy and procedures.
- Provide leadership to all staff in the areas of quality improvement as it relates to process improvement, customer service and conflict resolution.
- Prepare reports and briefings for project leadership and review monthly and quarterly project status reports provided to the Department.
Minimum Requirements
- Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience.
- Must be willing and able to travel up to 25% of the time as business need dictates.
- Lean Six Sigma experience with a minimum of Yellow Belt Certification required.
- Experience managing direct reports remotely required.
- Experience with designing, implementing and reporting customer satisfaction surveys required.
- Experience with standardized quality tools required.
- Experience with call and voice monitoring platforms required.
- Experience with a large-scale telephony system required.
- Experience with Client Relationship Management (CRM) platforms required.
- Experience with contract compliance and quality platforms required.
- Experience with statistical processes required.
- Premium contact center billing experience required.
- Financial experience with Oracle preferred.
Home Office Requirements:
- Internet speed of 20mbps or higher required (you can test this by going to *******************
- Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router.
- Must currently and permanently reside in the Continental US.
#max Priority
EEO Statement
Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics.
Pay Transparency
Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances.
Accommodations
Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************.
Minimum Salary
$
80,000.00
Maximum Salary
$
95,000.00
$65k-93k yearly est. Easy Apply 5d ago
Production Q&A Manager
Thomas Lane 4.0
Twinsburg, OH jobs
Production Q&A Manager - School Meal Program
Monday-Friday | No Evenings | No Weekends | Weekly Pay
Innovation Food Service is seeking an experienced and motivated Production Q&A Manager to help lead our growing school meal program. This position plays a key role in managing daily production operations while overseeing procurement, menu creation, and vendor relationships to ensure efficiency, quality, and compliance.
If you're a strong leader with a background in food production, safety, and purchasing-and you're looking for a stable schedule with great benefits-this opportunity is for you.
What You'll Do
Oversee daily production through floor Supervisors to ensure consistent quality, efficiency, and compliance.
Maintain food safety, labeling, and sanitation standards across all production areas.
Coordinate production schedules with procurement and menu planning to align with daily and weekly requirements.
Lead menu creation and updates-ensuring recipes are cost-effective, compliant, and appealing for school meal programs.
Manage purchasing of food, packaging, and supplies to maintain quality and cost control.
Develop and maintain vendor relationships to ensure consistent supply and pricing stability.
Support business development initiatives through cost analysis, sourcing, and new product development.
Review production records, temperature logs, and labeling for accuracy and compliance.
Lead, train, and support Supervisors and production teams to uphold company standards.
What You Bring
2+ years of experience in food production management, procurement, or supply chain.
Strong knowledge of food safety, sanitation, and quality control.
Experience with menu planning, costing, and portion control.
Excellent organizational, leadership, and communication skills.
Proven ability to manage budgets, vendor negotiations, and inventory.
Familiarity with school nutrition or institutional food programs preferred.
Ability to lift and move up to 50 lbs. as needed.
What We Offer
Monday-Friday schedule (no nights or weekends!)
Health, Dental & Vision Insurance
Life & Short-Term Disability Insurance
Pet Insurance
401(k) with Company Match
Paid Time Off & Holidays
Referral Program & Childcare Discounts
Company-Provided Lunch Daily
Passionate, Supportive Team
Weekly Pay
Salary: $60,000 - $70,000
Join a company that values your expertise, your time, and your quality of life.
Visit ifsmeals.com to learn more about our company and current opportunities.
$60k-70k yearly 60d+ ago
Director of Quality and Patient Safety
Ohiohealth 4.3
Mansfield, OH jobs
**We are more than a health system. We are a belief system.** We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities.
** Summary:**
This role works to support and align people and resources across multiple sites or units to empower, equip and engage all associates and clinicians to improve clinical quality and eliminate preventable harm.
The role is responsible for a portfolio of OhioHealth care sites, facilities, or business units, or for a portfolio of quality initiatives that span the entire system. The role collaborates closely with the peer regional directors and the System Directors of Quality and Patient Safety as well as the Clinical Enterprise in leading or contributing to the system quality and safety initiatives.
This position has an overall accountability to provide strategic direction, leadership, alignment, and integration of initiatives consistent with the expectations of enterprise leadership, external agencies, and accreditation standards, as well as align with the mission, vision, values, and goals of OhioHealth. The areas of responsibility include clinical quality, accreditation, patient safety, clinical standardization, peer review/OPPE, required reporting abstraction, health equity and other clinical excellence initiatives.
The role interfaces with the various site leadership teams and includes development of site-specific leaders to support this role. He/she utilizes a relationship-based and teamwork approach to integrate a culture of quality, continuous survey readiness, patient safety and innovation across practitioners, care delivery sites and continuum of care to achieve top decile performance, reduction of defects and recognition as a high reliability organization.
Assists in prioritization and resource allocation that aligns with the strategic quality goals of the organization. Provides project/process management consultation and leadership in the areas of rapid cycle learning, improvement thinking based on the scientific method (LEAN), and knowledge management to develop associates to balance organizational needs with internal capabilities. Serves as liaison to OhioHealth business partners, state/national boards, and associations.
This role supports core competencies of people development, results drive and culture builder.
**Responsibilities And Duties:**
Responsible for overall operations of clinical quality, patient safety, clinical standardization, accreditation, and other clinical excellence initiatives for assigned portfolio. Develops and implements initiatives and supplies resources that support the OH Strategic Plan, Quality Assessment and Performance Improvement and the OH Patient Safety Plan. Facilitates strategic planning and goal deployment, and engagement of physicians, clinicians and administrative staff in process improvement programs that raise the standard of patient care and safety. Leads or contributes to system quality and safety initiatives. Supports core competencies of people development, results driver, and culture builder.
25% - Oversight of Local QAPS teams and processes Provides leadership and prioritization of appropriate work and operations of clinical quality, patient safety, clinical standardization, accreditation, and other clinical excellence initiatives for assigned areas of the business, which may span a broad geographic region. Providing vision, direction, and resource support of related initiatives with the goal of helping each OH site to improve the standard of patient care to achieve top decile performance. Develops the manager(s) to be key contact for day-to-day operations. Identifies and implements efficiencies amongst the regional sites.
25% - Collaboration with local leadership teams Develops and maintain relationships with physician quality leaders, hospital executives and clinical-administrative leaders to optimally facilitate all quality, patient safety and clinical standardization initiatives. Acts as coach and thought partner to caresite and system leaders. Maintains reporting relationships with local leadership teams on a regular basis including leadership team meetings, attends key medical staff meetings and compiles data and reports for key hospital meetings. May involve attending and reporting out at Governance Council, Board meetings, MECs, etc.
30% - System Quality and Patient Safety RoleWorks under the direction of System Quality and local leadership in the prioritization of work in each area of the work. Leads and/or engages in system work teams focused on the balanced scorecard or other defined priority work. Encourages and includes care site participation in system teams. Develops and implements communication and change management strategies that keep all levels of the organization senior executives, physician leadership and associates informed and engaged in patient safety, clinical quality, and error reduction programs.
10%Works with system analytics to supports the analysis and communication of patient safety event and quality indicator data and uses this information to evaluate the success of patient safety and clinical quality programs. Makes recommendations to senior leadership to enhance or refine priorities and processes. May contribute to updates relating to scorecard support or other operationally driven clinical data opportunities.
10% - Development and EducationAssists in development and support of the personal and professional development of QPS managers and associates. Leads education and training in problem solving methodology and provides continuous feedback to the local teams.
The major duties, responsibilities and listed above are not intended to be all-inclusive of the duties, responsibilities and to be performed by employees in this job. This associate is expected to perform all other duties as requested by supervisor.
Requires travel to and between OhioHealth care sites and other facilities.
**Minimum Qualifications:**
Master's Degree (Required) RN - Registered Nurse - Ohio Board of Nursing
**Additional Job Description:**
**SPECIALIZED KNOWLEDGE**
Advanced degree in a healthcare-related field (Master's or above), or advanced degree in business with prior experience leading a healthcare Quality team. In depth knowledge of hospital systems including but not limited to practices, operations, and support services.
Experience with and knowledge of continuous improvement philosophies and tools, including Lean management systems, coaching and improvement katas. Expertise in error prevention training, root cause analysis, apparent cause analysis and common cause analysis, process improvement methodologies, project management methodologies. Understanding of the application of clinical quality data, decision support systems, event reporting/tracking systems. Strong background in change management.
Established skills in strategy development and work prioritization, leadership, facilitation, negotiation, consensus building, organization, time management, team building, and conflict identification and resolution. Excellent teaching and presentation skills. Outstanding listening, interpersonal relationship building, and problem-solving skills. Able to prioritize and manage multiple projects simultaneously with demonstrated ability to complete projects successfully on time and within budget.
Experience working in complex matrix organizations, building trusting relationships, influencing, and aligning diverse stakeholders to achieve a common vision. Ability to engage physicians, peers, and other members of the healthcare team in supporting quality initiatives. Understands administrative concepts, organizational behavior, legal and ethical matters, healthcare economics, health and public policy, consumer health issues and outcomes measures.
**Work Shift:**
Day
**Scheduled Weekly Hours :**
40
**Department**
Quality and Patient Safety
Join us!
... if your passion is to work in a caring environment
... if you believe that learning is a life-long process
... if you strive for excellence and want to be among the best in the healthcare industry
Equal Employment Opportunity
OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment
$111k-136k yearly est. 27d ago
Director of Quality and Patient Safety
Ohio Health 3.3
Mansfield, OH jobs
We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities.
Summary:
This role works to support and align people and resources across multiple sites or units to empower, equip and engage all associates and clinicians to improve clinical quality and eliminate preventable harm.
The role is responsible for a portfolio of OhioHealth care sites, facilities, or business units, or for a portfolio of quality initiatives that span the entire system. The role collaborates closely with the peer regional directors and the System Directors of Quality and Patient Safety as well as the Clinical Enterprise in leading or contributing to the system quality and safety initiatives.
This position has an overall accountability to provide strategic direction, leadership, alignment, and integration of initiatives consistent with the expectations of enterprise leadership, external agencies, and accreditation standards, as well as align with the mission, vision, values, and goals of OhioHealth. The areas of responsibility include clinical quality, accreditation, patient safety, clinical standardization, peer review/OPPE, required reporting abstraction, health equity and other clinical excellence initiatives.
The role interfaces with the various site leadership teams and includes development of site-specific leaders to support this role. He/she utilizes a relationship-based and teamwork approach to integrate a culture of quality, continuous survey readiness, patient safety and innovation across practitioners, care delivery sites and continuum of care to achieve top decile performance, reduction of defects and recognition as a high reliability organization.
Assists in prioritization and resource allocation that aligns with the strategic quality goals of the organization. Provides project/process management consultation and leadership in the areas of rapid cycle learning, improvement thinking based on the scientific method (LEAN), and knowledge management to develop associates to balance organizational needs with internal capabilities. Serves as liaison to OhioHealth business partners, state/national boards, and associations.
This role supports core competencies of people development, results drive and culture builder.
Responsibilities And Duties:
Responsible for overall operations of clinical quality, patient safety, clinical standardization, accreditation, and other clinical excellence initiatives for assigned portfolio. Develops and implements initiatives and supplies resources that support the OH Strategic Plan, Quality Assessment and Performance Improvement and the OH Patient Safety Plan. Facilitates strategic planning and goal deployment, and engagement of physicians, clinicians and administrative staff in process improvement programs that raise the standard of patient care and safety. Leads or contributes to system quality and safety initiatives. Supports core competencies of people development, results driver, and culture builder.
25% - Oversight of Local QAPS teams and processes Provides leadership and prioritization of appropriate work and operations of clinical quality, patient safety, clinical standardization, accreditation, and other clinical excellence initiatives for assigned areas of the business, which may span a broad geographic region. Providing vision, direction, and resource support of related initiatives with the goal of helping each OH site to improve the standard of patient care to achieve top decile performance. Develops the manager(s) to be key contact for day-to-day operations. Identifies and implements efficiencies amongst the regional sites.
25% - Collaboration with local leadership teams Develops and maintain relationships with physician quality leaders, hospital executives and clinical-administrative leaders to optimally facilitate all quality, patient safety and clinical standardization initiatives. Acts as coach and thought partner to caresite and system leaders. Maintains reporting relationships with local leadership teams on a regular basis including leadership team meetings, attends key medical staff meetings and compiles data and reports for key hospital meetings. May involve attending and reporting out at Governance Council, Board meetings, MECs, etc.
30% - System Quality and Patient Safety RoleWorks under the direction of System Quality and local leadership in the prioritization of work in each area of the work. Leads and/or engages in system work teams focused on the balanced scorecard or other defined priority work. Encourages and includes care site participation in system teams. Develops and implements communication and change management strategies that keep all levels of the organization senior executives, physician leadership and associates informed and engaged in patient safety, clinical quality, and error reduction programs.
10%Works with system analytics to supports the analysis and communication of patient safety event and quality indicator data and uses this information to evaluate the success of patient safety and clinical quality programs. Makes recommendations to senior leadership to enhance or refine priorities and processes. May contribute to updates relating to scorecard support or other operationally driven clinical data opportunities.
10% - Development and EducationAssists in development and support of the personal and professional development of QPS managers and associates. Leads education and training in problem solving methodology and provides continuous feedback to the local teams.
The major duties, responsibilities and listed above are not intended to be all-inclusive of the duties, responsibilities and to be performed by employees in this job. This associate is expected to perform all other duties as requested by supervisor.
Requires travel to and between OhioHealth care sites and other facilities.
Minimum Qualifications:
Master's Degree (Required) RN - Registered Nurse - Ohio Board of Nursing
Additional Job Description:
SPECIALIZED KNOWLEDGE
Advanced degree in a healthcare-related field (Master's or above), or advanced degree in business with prior experience leading a healthcare Quality team. In depth knowledge of hospital systems including but not limited to practices, operations, and support services.
Experience with and knowledge of continuous improvement philosophies and tools, including Lean management systems, coaching and improvement katas. Expertise in error prevention training, root cause analysis, apparent cause analysis and common cause analysis, process improvement methodologies, project management methodologies. Understanding of the application of clinical quality data, decision support systems, event reporting/tracking systems. Strong background in change management.
Established skills in strategy development and work prioritization, leadership, facilitation, negotiation, consensus building, organization, time management, team building, and conflict identification and resolution. Excellent teaching and presentation skills. Outstanding listening, interpersonal relationship building, and problem-solving skills. Able to prioritize and manage multiple projects simultaneously with demonstrated ability to complete projects successfully on time and within budget.
Experience working in complex matrix organizations, building trusting relationships, influencing, and aligning diverse stakeholders to achieve a common vision. Ability to engage physicians, peers, and other members of the healthcare team in supporting quality initiatives. Understands administrative concepts, organizational behavior, legal and ethical matters, healthcare economics, health and public policy, consumer health issues and outcomes measures.
Work Shift:
Day
Scheduled Weekly Hours :
40
Department
Quality and Patient Safety
Join us!
... if your passion is to work in a caring environment
... if you believe that learning is a life-long process
... if you strive for excellence and want to be among the best in the healthcare industry
Equal Employment Opportunity
OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment
$78k-100k yearly est. Auto-Apply 27d ago
Quality Manager
Galion LLC 3.9
Galion, OH jobs
Job DescriptionDescription:
Galion LLC is seeking a highly motivated Quality Manager to join our management team.
Responsible for providing, implementing, and maintaining AS9100 Quality Assurance Systems, procedures and standards to ensure product quality conformance consistent with contract requirements. Works on a regular basis with production area supervisors, production control, government representatives, vendors, purchasing, and line personnel.
Requirements:
Duties:
•Determines job priorities and distributes
•Schedules workload distribution within the Quality department
•Responsible for overseeing all internal and external problem analysis of Corrective Actions and internal rejects and/or repairs
•Generates weekly/monthly quality reports based on daily inspections which will contain machine, operator, product, and process capabilities
•Accountable for the preparation and control of all Quality Assurance Procedures, inspection reports and Quality Control documentation, and Quality Control standards including overseeing the Gage Lab
•Supports continuous improvements
•Responsible for monitoring / contracting internal / external quality activities over multiple shifts
•Strong customer relationships ensuring all requirements are met
•Other job duties as assigned
Requirements:
•Minimum ten (10) years in Quality Management position preferred
•Bachelor's degree or a degree in a related field
•Quality system comprehension - AS 9100 and MIL-Standards
•Must have strong computer skills and be proficient in MS Office products
•Good written and verbal skills necessary
•ASQ certification a plus
•Familiar with USG contracts and quality requirements a plus
•Strong communication skills with internal employees and external contacts
This is a full-time position offering competitive benefits including medical, dental, vision insurance, paid time off, performance bonuses, 401(k) with company match, and ongoing training opportunities.
Equal Opportunity Employer
Job Type: Full-time
Benefits:
•401(k)
•401(k) matching
•Dental insurance
•Employee assistance program
•Health insurance
•Life insurance
•Paid time off
•Referral program
•Retirement plan
•Tuition reimbursement
•Vision insurance