Post job

Quality Engineer jobs at Teleflex

- 1505 jobs
  • Supervisor , Continuous Quality Monitoring

    Regal Medical Group 3.8company rating

    Los Angeles, CA jobs

    The CQM Supervisor oversees non-clinical auditors in the Clinical Quality Management (CQM) department, ensuring regulatory compliance and the quality of processes in daily Non-Clinical Utilization Management (UM) activities, under the direction of a manager. This Supervisor is responsible for conducting live audits of UM case files, assigning drivers and presenters, and ensuring their performance is appropriate. The role also involves monitoring UM system controls and processes, specifically those that do not require clinical decisions. A solid understanding of comprehensive regulations, UM policies and procedures, the UM system, UM auditing, and quality improvement is essential for this position. Essential Duties and Responsibilities: - Familiarity with Non-Clinical UM regulations, processes, and systems. - Ability to assign workloads effectively while managing staff. - Proficient in presenting case files and conducting interviews regarding non-clinical questions. - Skilled in designing audit tools to monitor Non-Clinical UM processes completed by non-clinical staff. - Strong communication skills for effective interaction with internal clients and external customers. - Capable of training employees using Policies & Procedures (P&Ps) and audit tools. - Provide constructive feedback and exhibit strong active communication skills. - Summarize quality monitoring findings, analyze root causes, and propose quality improvement plans. - Suggest and design focused audits that help improve compliance in Non-Clinical UM processes. - Request decision support for creating and enhancing Non-Clinical UM monitoring reports based on changes to UM P&Ps. - Ensure auditors complete audits and necessary remediation within specified timeframes. - Collaborate with the Non-Clinical UM team to ensure monitored focus areas are addressed and that process quality is tracked. - Work with operational teams to evaluate the effectiveness and efficiency of process changes made for quality improvement. - Ensure that new processes are accurately implemented through reports and case file reviews. - Report issues identified to the Prior Authorization Compliance Director based on findings. - Review updated policies and procedures, and be able to update the quality monitoring tool accordingly. - Maintain all evidence related to quality monitoring projects. - Track and manage daily reports received from the decision support team. - Report any issues related to internal processes (e.g., timeliness) to the CQM manager. - Attend department meetings, in-house services, and trainings, completing acknowledgments within the required timeframe. - Perform all other duties as directed by management. Education and Experience: - Three to five (3-5) years of experience in non-clinical utilization management. - Preferred: at least two (2) years of experience in non-clinical UM supervision or auditing. - Proficiency in MS Office programs (Word, Excel, Outlook, Access, PowerPoint). - Typing speed of 60 words per minute with accuracy. - Ability to handle confidential matters responsibly. - Strong analytical, creative problem-solving, and organizational skills. - Capacity to work in a multi-tasking, high-stress environment. - Effective strategy execution within timelines, delivering quality results. - Ability to adapt and thrive in a fast-paced environment, demonstrating proactivity. - Capable of managing multiple projects simultaneously, adjusting priorities daily, and knowing when to seek assistance with conflicting priorities. - Self-motivated, assertive, ambitious, and possessing high personal ethics. - Ability to collaborate with all levels of management and establish positive working relationships across various divisions in the company. Compensation: The pay range for this position at the start of employment is expected to be between $70,304 and $72,000 annually, depending on experience. However, the base pay offered may vary based on multiple individual factors, including market location, job-related knowledge, licensure, skills, and overall experience. The total compensation package for this position may also include other elements, such as a sign-on bonus and discretionary awards, along with a full range of medical, financial, and other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), depending on the position offered. Details regarding participation in these benefit plans will be provided to employees who receive an employment offer. If hired, the employee will be in an “at-will position,” and the company reserves the right to modify base salary (along with any other discretionary payments or compensation programs) at any time, including for reasons related to individual performance, overall company performance, or market factors. As one of the fastest-growing Independent Physician Associations in Southern California, Regal Medical Group, Lakeside Community Healthcare, and Affiliated Doctors of Orange County offer a dynamic and fast-paced work environment. Employer will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the LA City Fair Chance Initiative for Hiring Ordinance.
    $70.3k-72k yearly 2d ago
  • RN Quality Program Manager - Oncology

    Providence Health and Services 4.2company rating

    Bellevue, WA jobs

    Quality Program Manager RN - Oncology @ Swedish First Hill Full time Day shift Fantastic benefits and compensation package offered by Providence that begin on your first day of employment. Join us, and find out how many ways we offer you the chance to focus on what really matters - our patients. This role is responsible for regulatory compliance and quality standards in accordance with Foundation for the Accreditation of Cellular Therapy (FACT) guidelines. Under the direction of operational and clinical leadership, the Supervisor leads the compliance audits, corrective action process, and other quality and compliance activities designated in the Quality Management Plan and Audit Calendar. Ensures compliance with FACT, CIBMTR, and other applicable agencies by continually engaging agencies around updates, identifying and updating internal SOPs to reflect changes, and coordinating and documenting education to necessary parties. Regularly reviews status of annual competency requirements, identifies avenues to assist in meeting requirements, and notifies participants of any deficiencies throughout the year. Partners with IS, Best Practice, Clinical Transformation, analytics, patient engagement, patient safety, risk management and other teams to coordinate improvements in education, workflow, Epic, and other areas identified by project teams. Will participate in Quality Management Committee meetings/Transplant CPC meetings and collaborate with various clinical departments for planning, coordination, implementation, and monitoring of all quality management activities throughout the service line. Manages the Quality Calendar and performs associated audits. Shares audit results with leadership, proposes and implements corrective action plans. Participates in the design, creation, validation, analysis, and communication of clinical quality data as it related to organizational priorities in partnership with analytics and other relevant teams. Works closely with Data Managers to ensure data integrity and quarterly CPI requirements are met. Supports the evaluation and continual improvement of quality and safety at Swedish, as represented by the quality management system and/or other standardized practices across the enterprise. Uses standardized principles (i.e., document vetting and control) and processes (i.e., internal audits, preventative/corrective action, risk reduction, action planning) as appropriate. Remains current and knowledgeable about regulatory requirements and payor/government programs such as FACT and CIBMTR. References that information to design effective systems and processes and meets or exceeds those standards. Creates project summaries and reports, leads project committees/workgroups, and provides presentations and other communications to local and system-wide groups/teams in partnership with division leadership as needed. Participates thoughtfully and constructively in team meetings. Assists with onboarding of new team members. Maintains minimum 10 hours of cellular therapy education. Providence caregivers are not simply valued - they're invaluable. Join our team at Swedish First Hill and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them. Required Qualifications: Bachelor's Degree Nursing; graduation from an accredited school. Upon hire: Washington Registered Nurse License. Upon request: Driving may be necessary as part of this role. Caregivers are required to comply with all state laws and requirements for driving. Caregivers will be expected to provide proof of driver license and auto insurance upon request. 3 years Direct patient care. Experience with EHRs. Experience developing clinical care policies, procedures and order sets. Preferred Qualifications: Master's Degree Healthcare. 1 year Experience in a supervisory role; delegating nursing responsibilities to licensed and unlicensed personnel within a medical setting (ambulatory or acute). Why Join Providence? Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally and achieving financial security. We take care of you, so you can focus on delivering our mission of improving the health and wellbeing of each patient we serve. About Providence At Providence, our strength lies in Our Promise of “Know me, care for me, ease my way.” Working at our family of organizations means that regardless of your role, we'll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable. Posted are the minimum and the maximum wage rates on the wage range for this position. The successful candidate's placement on the wage range for this position will be determined based upon relevant job experience and other applicable factors. These amounts are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits. Applicants in the Unincorporated County of Los Angeles: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Unincorporated Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Requsition ID: 405697 Company: Swedish Jobs Job Category: Clinical Quality Job Function: Quality/Process Improvements Job Schedule: Full time Job Shift: Day Career Track: Nursing Department: 3901 SFH HEM ONCOLOGY Address: WA Seattle 1221 Madison Work Location: Swedish First Hill 1221 Madison-Seattle Workplace Type: On-site Pay Range: $57.86 - $89.83 The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. PandoLogic. Category:Quality Control, Keywords:Quality Control / Quality Assurance Manager, Location:Bellevue, WA-98005
    $57.9-89.8 hourly 4d ago
  • Organizational Quality Nurse Specialist

    Hospice of Michigan 4.7company rating

    Ann Arbor, MI jobs

    Responsible for maintaining compliance with all State, Federal regulatory guidelines and third party payers; Accreditation standards and quality activities of the organization. Provides leadership and expertise to facilitate and support staff competency through best practice teaching, consultation, collaboration and the use of current knowledge, research and technology. Essential Functions: Ensures that there are processes in place to monitor and measure all activities related to quality assessment and performance improvement (QAPI). Provides direction and coordination of quality improvement activities utilizing continuous quality improvement principles and methodologies. Provides education and training to organization personnel on the QAPI plan, and team development. Performs clinical record review activities for data collection. Compiles, analyzes, trends and reports quality data in the following areas: hospice & palliative care quality reporting, patient care, safety, risk management, infection control, outcomes and customer satisfaction. Works collaboratively with nursing supervisors/managers/directors to assure documentation is complete and consistent with care and reflects legal requirements. Promotes professional standards of care, compliance with regulatory requirements, third-party payor reimbursement models, and organization policies and procedures through use of performance improvement methodology. Ensures complete responses to Additional Development Requests (ADRs), Comprehensive Error Rate Testing (CERT), Recovery Audit Contractor (RAC) etc., requests and participates in appeal processes. Participates in the development and annual revision of Quality Assessment and Improvement Plans and Program Evaluation. Participates in analyzing, developing, coordinating and implementing plans of correction for noted deficiencies. Makes recommendations to the education committee for mandatory education related to accreditations and compliance topics. Acts as a mentor and resource for staff with regard to performance improvement methodology, regulatory, educational and patient care issues. Participates in the evaluation, development and revision of policies and procedures for hospice. Participates on various committees related to Organizational Quality and Education. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal and professional networks. Adheres to organizational Code of Conduct, policies, procedures, protocols and processes and all regulatory and legal requirements Adheres to the C.A.R.E. Model of Service: courtesy, acknowledgement, response and empathy. Qualifications: Registered Nurse with a baccalaureate degree in nursing, preferably a Master's Degree in a health-related discipline. Minimum three (3) years' direct hospice experience may be considered in lieu of BSN degree. Requires two to three years related quality and accreditation experience. Current RN licensure in State of Michigan and maintain such licensure in accordance with applicable laws and regulations and perform within the scope specified. Extensive knowledge of Hospice regulations and standards preferred. Excellent written, verbal and interpersonal skills necessary to interact with a wide variety of staff. Is self-directed and able to work with minimal supervision. Requires knowledge of quality assessment and utilization review functions, principles and practices. Theoretical and practical knowledge of principles of adult learning and ability to develop and present educational programs. Quantitative, analytical and computer skills to collect, analyze, display and present data. The physical and sensory demands of the position include: vision, effective speech and hearing for extensive telephone contact; repetitive motion; traveling; driving or riding in motor vehicle; standing, sitting, walking, bending, reaching, and stretching; lifting up to forty five (45) pounds unassisted and the ability to assist in lifting patients using appropriate lifting techniques and/or devices. Must be able to work variable hours/shifts and/or days, including weekends. Must have ability to occasionally work extended days. Must be eligible to work in the United States.
    $80k-97k yearly est. 3d ago
  • Materials Engineer

    Veridiam 4.2company rating

    El Cajon, CA jobs

    Veridiam is a strategic manufacturing partner specializing in precision fabrication of components and assemblies made from exotic metals for critical applications in aerospace, defense, medical, nuclear, and space. Our roots were formed in the exacting nuclear and aerospace industries, expanded into medical where we have supplied critical components to a global customer base. Veridiam's ability to work with challenging materials such as titanium alloys, nickel-based superalloys, refractory metals, and specialty stainless steels ensures reliable, mission-ready products for our customers' most vital programs. As a trusted partner, Veridiam provides technical collaboration, quality assurance, and supply chain reliability essential to advancing innovation and operational success across these highly regulated industries and results for mission-critical parts made from titanium alloys, nickel-based superalloys, refractory metals and more. At Veridiam we recognize that talent is at the forefront of our organization and define who we are in today's industry. You will work in a highly regulated, precision manufacturing environment where safety, documentation integrity, dimensional control (“True Diameter”) and traceability are paramount. Veridiam is looking for a Materials Engineer for our El Cajon facility. Interested candidates should apply directly to our website at: Careers - Strategic Manufacturing Partner > Veridiam Position Summary Extract, research, develop, test, and improve materials used in our products and processes. Perform tests and conduct research on properties, performance and applications of metals including high-performance alloys. Analyze material behavior under various conditions and prepare technical reports. Essential Duties and Responsibilities Perform assigned routine and advanced or complex tests on raw material, product in process, re-worked material, finished goods and/or developmental samples in accordance with customer and/or quality standards/specifications. Conduct research on the properties, performance, and applications of metals including high-performance alloys such as stainless steel, titanium, and nickel alloys. Develop and test new materials to improve product durability, performance, and efficiency. Perform failure analysis and recommend design/material improvements. Analyze material behavior under various conditions (stress, temperature, corrosion, wear, etc.). Review and manage internal and external material lab test results. Develop and maintain processes for new product introduction. Prepare technical reports, specifications, and documentation for internal and customer use. Prepare, organize, and maintain necessary samples, forms, documentation and trend charts. May provide data and analysis to material review board to support resolution of issues, initial data support to supplier and/or customer notification. Ensure compliance with industry standards, safety regulations, and environmental requirements. Support process optimization and cost-reduction initiatives without compromising quality. Work collaboratively with cross-functional teams to ensure materials meet customer requirements and performance, quality and cost objectives. Provide and supply training for others in the area. Maintain clean and orderly work environment. Demonstrates ability to appear for work on time, follow directions from a supervisor, interact well with co-workers, understand and follow work rules and procedures, comply with company policies and procedures, goals and objectives, and accepts constructive feedback. Other duties as assigned, requested or needed. Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Education and Experience: Bachelor's degree in Materials Science, Materials Engineering, Metallurgy, Chemical Engineering or related field. Five (5) or more years' experience in manufacturing and/or familiarity of the international standards for testing metallic materials (ASTM E8) including steel products (ASTM A370) preferred or equivalent education and experience. Knowledge, Skills, and Abilities: Knowledge of metal forming, and/or machining methods preferred. Excellent written and verbal communication skills. Ability to read and interpret documents such as work orders, operating and maintenance instructions and procedure manuals and blueprints. Ability understand and follow standard operating and safety procedures. High-level attention to detail and commitment to quality standards. Strong problem-solving skills and technical expertise in materials science. The above statements are intended to describe, in broad terms, the general functions and responsibility levels assigned to this classification. Management has the right to change duties at any time to meet business needs. Pay Rate: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc. Veridiam is an Equal Employment Opportunity/Affirmative Action Employer. Veridiam will recruit, hire, train and promote persons into all jobs without regard to age, race, color, religion, ancestry, medical condition, sex, sexual orientation, gender identity, national origin, status as a veteran or status as an individual with a disability or any other characteristic or classification protected by law. Access to our facility (and, therefore, employment) is restricted under the International Traffic in Arms Regulations (ITAR) and/or Export Administration Regulations (EAR) to U.S. Citizens, lawful permanent residents of the United States and properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes.
    $77k-104k yearly est. 4d ago
  • Manufacturing Quality Engineer

    Quest Global 4.4company rating

    Charlotte, NC jobs

    The achievers and courageous challenge-crushers we seek, have the following characteristics and skills: What You will Do: Quest Global is seeking a highly organized and detail-oriented Quality Engineer to join our team. In this role, you will ensure compliance with quality standards and continuous improvement within Gas Turbines Rotor Components Machining Department. This role involves monitoring manufacturing processes, conducting root cause analysis, and implementing corrective/preventive actions to maintain product integrity and customer satisfaction. The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:• What You Will Do: Quality Assurance & Compliance Develop, implement, and maintain quality control procedures for rotor components machining processes. Ensure adherence to Siemens Energy quality standards and applicable industry standards. Inspection & Documentation Review engineering drawings, specifications, Prepare and maintain quality documentation, inspection reports, and RCAs, Corrective / preventive action records. Root Cause Analysis & Problem Solving Lead investigations using RCA, 8D, and CAPA methodologies for non-conformances. Drive corrective and preventive actions to eliminate recurring issues. Process Audits & Continuous Improvement Conduct internal/process audits of machining processes and identify improvement opportunities. Support Lean initiatives and process optimization projects. Collaboration & Communication Work closely with manufacturing engineers, machinists, and supervisors to resolve quality issues. Provide technical guidance and training on quality standards and best practices. What You Will Bring: Bachelor's degree in mechanical or manufacturing engineering. Minimum 7 years of experience in quality engineering within a machining or heavy manufacturing environment. Proficiency in quality tools: RCA, FMEA, PPAP and SPC Good understanding of CAD/CAM, CNC programming, and interpreting technical drawings with GD&T Strong knowledge of machining processes, CNC, CMM and precision components. Familiarity with SAP or similar ERP systems and Microsoft Office Suite. Certification in Six Sigma will be an added advantage Strong interpersonal skills Analytical and problem-solving skills with attention to detail. Ability to interpret complex engineering drawings and specifications. Strong communication and interpersonal skills for cross-functional collaboration. Knowledge of industry standards and regulatory requirements for turbine components. Ability to apply continuous improvement methods to increase manufacturing quality, efficiency, reliability, and cost effectiveness. Experience with advanced manufacturing processes Candidate should be familiar with Lean and or Six Sigma philosophies and their application in process capability and improvement Pay Range: (75K to 80K ). Compensation decisions are made based on factors including experience, skills, education, and other job-related factors, in accordance with our internal pay structure. We also offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan. Work Requirements: This role is considered an on-site position located in Charlotte, NC. You must be able to commute to and from the location with your own transportation arrangements to meet the required working hours. Shop floor environment, which may include but not limited to extensive walking, and ability to lift up to 40 lbs.
    $55k-65k yearly est. 4d ago
  • Software Quality & Operations Efficiency Engineer

    Aetrex, Inc. 4.6company rating

    Teaneck, NJ jobs

    Aetrex is the global leader in foot scanning technology. Our very latest scanner, Albert, was created over several years by a team of leading engineers and programmers and represents a major advance in technology for consumers and retailers alike. This revolutionary 3D system joins Aetrex's fleet of renown foot scanners, including Gaitway, Nova and Eclipse. The Aetrex technology development team consists of a diverse group of programmers that work together to create exciting User Interface and Experience for our customers. For over 20 years we have developed software for scanners and mobile devices that have helped millions of people experience relief from unnecessary foot pain. AlbertOS is a new, groundbreaking operating system that runs the Albert and Gaitway scanning devices and can be easily operated using simple voice or touch commands. Albert captures unmatched data and information about feet, enabling consumers to make more educated buying decisions when it comes to footwear and orthotic purchases. We're hiring a Software Quality & Operations Efficiency Engineer to join our team! This dual-focused role requires an individual who can tackle the complete automation of our software testing suite and improve the operational efficiency of the software in the field. The ideal candidate will bridge the gap between technical support and quality assurance. Key Responsibilities: I. Software Quality & Automation Framework Development Design, build, and maintain robust, scalable test automation frameworks. Develop and execute automated tests for both UI and APIs (e.g., Selenium WebDriver and Postman), integrating these into Testing frameworks. Participate in new software release testing cycles, providing critical technical feedback to the development team. II. Operational Efficiency & Tooling Develop, maintain, and execute powerful scripts (e.g., PowerShell, Bash) to automate routine system diagnostics, support tasks, and operational workflows. Create small internal tools using coding experience (Python experience is a major asset) to enhance diagnostic capabilities and streamline support processes. Document all testing, support, and automation processes clearly using tools like Confluence and manage workflow in Jira. III. Technical Support Resolve technical issues, providing effective, timely support to customers via phone, email, and remote sessions, with a strong emphasis on the Windows OS environment. Utilize SQL and database knowledge (including MySql) to perform complex data querying and analysis, ensuring data integrity during troubleshooting. Monitor and troubleshoot applications deployed on AWS cloud services, demonstrating foundational knowledge of EC2, S3, and CloudWatch. Requirements: 5+ years in Software Testing, Operations Monitoring, Technical Support, Help Desk, Quality Assurance or comparable technical role. Hands-on experience with a frontend testing tool (Selenium Web Driver/Playwright/TestSprite, etc) and a backend testing tool (Postman/SoapUI, etc). Strong proficiency in scripting (e.g., PowerShell, Bash). PowerShell is highly preferred. Solid understanding and hands-on experience with SQL for querying and troubleshooting. In-depth knowledge of Windows Operating Systems and associated configurations/troubleshooting. Familiarity with AWS Cloud Services: Practical experience troubleshooting or monitoring applications deployed on Amazon Web Services (AWS), including foundational knowledge of services like EC2, S3, or CloudWatch. Demonstrated ability to manage testing protocols and improve operations efficiency in a software environment. Excellent organizational skills, including the ability to generate clear reports and diligently manage follow-up tasks. Experience with a programming language; Python experience is a major asset.
    $73k-102k yearly est. 3d ago
  • Process Engineer

    Piping Rock Health Products 4.1company rating

    Aurora, OH jobs

    We're a “safety first high performance” culture driven by a zero waste and zero defect mentality set out to enrich the lives of humans everywhere. As a leading vitamin and food supplement manufacturer, we carry on the legacy of our Founder who led us to reshape the category. We have grown our passionate Piping Rock Family as we've grown our business. We are growing quickly, join the Piping Rock family and grow your career. As a Process Engineer, you'll be responsible for equipment re-design while implementing, controlling, and optimizing packaging/manufacturing processes and machinery to achieve organizational targets. You'll work hand in hand with Production and Engineering to help improve standards that enable high performing production processes in our facility. Additional responsibilities include defining equipment standards, leading process and benchmarking and reapplication, and building capability within teams to do technical troubleshooting and process improvement and understanding the Piping Rock Continuous Excellence program and the respective tools. Responsibilities: Analyze production loss data to identify and prioritize projects to be executed in factory's continuous improvement plan and develop technical mastery of the core production processes, driven by bottleneck/high losses. Lead v-curve analysis and balanced line flow studies and identify debottlenecking projects. Initiate, lead, and modify process/improvements that will increase throughput, reduce scrap, improve quality, and eliminate losses. Implement LEAN manufacturing methods. Drive and mobilize resources to conduct problem solving on systems or equipment through failure modes & effects analysis (FMEA) and other Six Sigma methodology. Develop productivity standards, collect data to publish KPI and OEE reports. Participate in planning, commissioning, and startup of new equipment/processes. Creating and improving standards that enable sustainability of high preforming production processes and supporting training programs that develop high performing operators and technicians and. Collaborating with technical experts, other functions, and other factories to create and replicate optimal solutions/best practices. Establish operating parameters for each equipment by product to obtain reliable and efficient production Responsible for working directly on the manufacturing lines and assisting mechanics during repairs to understand the process workflow. Work schedule flexibility to overlap with other shifts as needed. Other duties as assigned. Qualifications: Bachelor's degree in an engineering field, preferably Industrial and Systems Engineering 3+ years of project/ process management experience in a manufacturing, or packaging environment. Or Associates degree in a technical field. 7+ years of project/ process management experience in a manufacturing, or packaging environment. Preferred Skills: Six Sigma or Lean certification. Experience with process automation and control systems. GMP environment a plus Must be able to lift 30lbs Must be able to stand for 8 hours Must be able to work in a physically challenging environment. We proudly offer: Medical, Dental, Vision, 401K with Company Match, Pet insurance and more! We reward the hard work of our team members with fun and exciting company events, Summer Picnic, Festive Packages, Holiday Celebrations, and associate referral bonuses! Founded in 2011, Piping Rock Health Products has gone on to win Long Island's Top Workplaces Award 6 years in a row & securing the spot as Top Supplement Manufacturing Company 2024 by Food Business Review! Supported by a group of vitamin visionaries with over 40 years of industry experience and a carefully curated team of talented associates. Piping Rock is a global vitamin and supplement manufacturer with an unwavering commitment to creating quality wellness products. We believe that family always comes first, and that the dedication of our associates is the key ingredient to our success. We are drug free workplace, regulated by the FDA, required to follow Federal Guidelines; therefore in order to start as well as maintain employment, you must be able to successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines. Piping Rock Health Products, INC is an Equal Opportunity Employer.
    $61k-79k yearly est. 2d ago
  • Manager, Quality and Manufacturing

    Hello Heart 3.9company rating

    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 10d ago
  • RN Quality Program Manager - Oncology

    Providence Health & Services 4.2company rating

    Seattle, WA jobs

    Quality Program Manager RN - Oncology @ Swedish First Hill Full time Day shift Fantastic benefits and compensation package offered by Providence that begin on your first day of employment. Join us, and find out how many ways we offer you the chance to focus on what really matters - our patients. This role is responsible for regulatory compliance and quality standards in accordance with Foundation for the Accreditation of Cellular Therapy (FACT) guidelines. Under the direction of operational and clinical leadership, the Supervisor leads the compliance audits, corrective action process, and other quality and compliance activities designated in the Quality Management Plan and Audit Calendar. + Ensures compliance with FACT, CIBMTR, and other applicable agencies by continually engaging agencies around updates, identifying and updating internal SOPs to reflect changes, and coordinating and documenting education to necessary parties. Regularly reviews status of annual competency requirements, identifies avenues to assist in meeting requirements, and notifies participants of any deficiencies throughout the year. + Partners with IS, Best Practice, Clinical Transformation, analytics, patient engagement, patient safety, risk management and other teams to coordinate improvements in education, workflow, Epic, and other areas identified by project teams. Will participate in Quality Management Committee meetings/Transplant CPC meetings and collaborate with various clinical departments for planning, coordination, implementation, and monitoring of all quality management activities throughout the service line. + Manages the Quality Calendar and performs associated audits. Shares audit results with leadership, proposes and implements corrective action plans. + Participates in the design, creation, validation, analysis, and communication of clinical quality data as it related to organizational priorities in partnership with analytics and other relevant teams. Works closely with Data Managers to ensure data integrity and quarterly CPI requirements are met. + Supports the evaluation and continual improvement of quality and safety at Swedish, as represented by the quality management system and/or other standardized practices across the enterprise. Uses standardized principles (i.e., document vetting and control) and processes (i.e., internal audits, preventative/corrective action, risk reduction, action planning) as appropriate. + Remains current and knowledgeable about regulatory requirements and payor/government programs such as FACT and CIBMTR. References that information to design effective systems and processes and meets or exceeds those standards. + Creates project summaries and reports, leads project committees/workgroups, and provides presentations and other communications to local and system-wide groups/teams in partnership with division leadership as needed. + Participates thoughtfully and constructively in team meetings. Assists with onboarding of new team members. + Maintains minimum 10 hours of cellular therapy education. Providence caregivers are not simply valued - they're invaluable. Join our team at Swedish First Hill and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them. Required Qualifications: + Bachelor's Degree Nursing; graduation from an accredited school. + Upon hire: Washington Registered Nurse License. + Upon request: Driving may be necessary as part of this role. Caregivers are required to comply with all state laws and requirements for driving. Caregivers will be expected to provide proof of driver license and auto insurance upon request. + 3 years Direct patient care. + Experience with EHRs. + Experience developing clinical care policies, procedures and order sets. Preferred Qualifications: + Master's Degree Healthcare. + 1 year Experience in a supervisory role; delegating nursing responsibilities to licensed and unlicensed personnel within a medical setting (ambulatory or acute). Why Join Providence? Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally and achieving financial security. We take care of you, so you can focus on delivering our mission of improving the health and wellbeing of each patient we serve. About Providence At Providence, our strength lies in Our Promise of "Know me, care for me, ease my way." Working at our family of organizations means that regardless of your role, we'll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable. Posted are the minimum and the maximum wage rates on the wage range for this position. The successful candidate's placement on the wage range for this position will be determined based upon relevant job experience and other applicable factors. These amounts are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits. Applicants in the Unincorporated County of Los Angeles: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Unincorporated Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Requsition ID: 405697 Company: Swedish Jobs Job Category: Clinical Quality Job Function: Quality/Process Improvements Job Schedule: Full time Job Shift: Day Career Track: Nursing Department: 3901 SFH HEM ONCOLOGY Address: WA Seattle 1221 Madison Work Location: Swedish First Hill 1221 Madison-Seattle Workplace Type: On-site Pay Range: $57.86 - $89.83 The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities.
    $57.9-89.8 hourly Auto-Apply 9d ago
  • Provider Network Quality Strategy Program Manager

    Commonwealth Care Alliance 4.8company rating

    Boston, MA jobs

    011230 CA-Provider Engagement & Performance The Program Manager, in collaboration with the Sr Director of Delegation Partnerships and Performance, is responsible for advancing provider quality performance across CCA's contracted network, with a focus on value-based arrangements and network-wide engagement strategies. The program manager is responsible for managing and implementing key population health and network quality initiatives to achieve high performance on CCA's Population Health goals; including Medicare Star measures, Medicaid-Medicare Plan withhold measures, quality performance metrics incorporated into other CCA contracts, health equity, Culturally and Linguistically Appropriate Services, Consumer Assessment of Healthcare Providers and Systems (CAHPS), and social determinants of health (SDOH) measures. The Program Manager will work collaboratively with our provider network and Quality teams to identify quality metrics that align contracting efforts for efficiency and effectives with alternative payment models. The Program This role serves as a critical bridge between Provider Engagement, Network Performance, Analytics, Clinical and Quality Teams to drive improvement in clinical outcomes, health equity, and member and provider experience. Supervision Exercised No direct reports currently; however, one to three program consultants with future expansion. Essential Duties & Responsibilities: Provider Quality Performance and Value-Based Care Lead implementation and monitoring of quality initiatives tied to value-based payment programs and contractual performance metrics. Partner with Provider Engagement, Network, Clinical and Quality teams to evaluate provider performance, identify opportunities for improvement, and facilitate data-driven action plans. Collaborate with Contracting, Quality Analytics, and Population Health to align provider quality measures with value-based contracts and incentive programs. Translate quality performance data into actionable insights and communicate findings to provider partners to drive improvement. Support the development and oversight of provider pay-for-performance programs, including metric tracking, financial reconciliation, and performance reporting. Health Equity and CLAS Integration Partner with the Health Equity team to incorporate CLAS (Culturally and Linguistically Appropriate Services) standards into provider education and engagement activities. Lead or support the development and dissemination of provider-facing resources that advance equitable care delivery. Coordinate provider training and communication initiatives focused on social drivers of health, cultural competence, and equity-focused performance improvement. CAHPS Strategy and Performance Oversee implementation of provider-focused initiatives that support CAHPS performance improvement. Analyze CAHPS results to identify trends and collaborate with Provider Network, Clinical and Quality teams to address performance gaps. Develop and disseminate provider education and best practices to improve member satisfaction with access, communication, and care coordination. Track and report provider performance metrics related to CAHPS domains such as Getting Needed Care, Getting Care Quickly, Rating of Health Care, and Customer Service. Collaborates with Communications to design provider materials and newsletters reinforcing CAHPS-related expectations and improvement goals. Partners with network leadership to recognize high-performing providers and share improvement strategies. Provider Education and Engagement Manage the design, scheduling, and delivery of provider quality education, including webinars, learning sessions, and quality performance updates in collaboration with Quality team. Develop materials and presentations that clearly communicate quality goals, contractual expectations, and best practices to the provider network. Serve as a trusted liaison to provider partners, responding to quality-related inquiries and facilitating collaborative discussions on improvement opportunities. Performance Reporting & Data Management Partner with Quality Analytics and Business Intelligence to ensure timely, accurate, and meaningful quality performance reporting to internal teams and providers. Monitor performance trends and support the creation of dashboards, summaries, and progress reports for internal and external audiences. Maintain documentation, SOPs, and reporting schedules to support consistent quality operations. Cross-Functional Collaboration & Strategic Support Collaborate closely with Provider Engagement, Contracting, Quality, and Clinical to ensure alignment on provider quality goals. Participate in cross-functional workgroups focused on quality improvement, network performance, and member and provider experience. Support strategic initiatives that promote continuous improvement and operational efficiency across the provider network. Working Conditions Remote or hybrid working conditions. Position requires occasional travel in Massachusetts and the surrounding area. Required Education: Bachelor's degree in healthcare administration, public health, business or health care related field Desired Education: Master's degree Certified Professional in Healthcare Quality (CPHQ) or equivalent certification Required Experience: 5-7 years of experience in healthcare quality improvement, provider network performance and management, population health, or related area Demonstrated experience interpreting and applying quality measures (HEDIS, CAHPS, HOS) and value-based contract performance metrics Experience with Medicare Advantage, Medicaid; and dually eligible populations Desired Experience Experience managing or supporting pay-for-performance or value-based care programs. Experience leading provider education or training sessions. Exposure to health equity initiatives and/or CLAS standards integration in provider settings. Required Knowledge, Skills & Abilities: Strong understanding of provider quality performance frameworks and value-based care principles. Working knowledge of claims data, quality measurement, and performance incentive methodologies. Excellent verbal and written communication skills, including the ability to synthesize and present data effectively to providers and internal stakeholders. Strong relationship management and interpersonal skills; ability to engage diverse provider partners diplomatically. Proficiency with Microsoft Office Suite (Excel, PowerPoint, Word) and comfort working with dashboards and analytics tools. Proven project management skills and ability to manage multiple priorities and deadlines. Self-directed, detail-oriented, and able to work effectively in a fast-paced, matrixed environment. Desired Knowledge, Skills & Abilities: Familiarity with quality analytics platforms, provider portals, or data visualization tools. Working knowledge of health plan claims and payment policies, including provider reimbursement methodologies. Experience applying CLAS standards or health equity frameworks within provider engagement or quality improvement initiatives. Language(s) English Compensation Range/Target: $99,600 - $149,400 Commonwealth Care Alliance takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package.
    $99.6k-149.4k yearly Auto-Apply 60d ago
  • Manager, Quality and Manufacturing

    Hello Heart 3.9company rating

    Menlo Park, CA jobs

    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 8d ago
  • Senior Product Quality Engineer

    Hologic 4.4company rating

    Marlborough, MA jobs

    Are you passionate about ensuring the quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role, you'll lead investigations into post-market feedback and complaints, conduct root cause analyses, and implement corrective or preventive actions to ensure our products meet the highest standards of quality and safety. Collaborating with cross-functional teams, you'll drive product and process improvements while making a meaningful impact on the lives of patients worldwide. If you're a proactive problem-solver with experience in quality, risk management, and engineering, we'd love to have you on our team! Knowledge: Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). Familiarity with test method validation, root cause failure analysis, and statistical methods. Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components. Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards. Skills: Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs). Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact. Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation. Ability to perform independent health risk assessments and present findings to leadership. Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership. Strong ability to assess and review written product and project documentation for compliance. Preferred: Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products. Behaviors: Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. Proactive and decisive, with the ability to independently prioritize tasks and resolve conflicts. Collaborative and team-oriented, with a focus on fostering productive working relationships across functions. Problem-solving mindset, focused on identifying root causes and driving effective solutions. Customer-focused, with a commitment to addressing product quality issues and ensuring customer satisfaction. Driven by continuous improvement, with a desire to optimize processes and enhance product quality. Experience: 5+ years of experience in engineering, preferably in a regulated industry such as medical devices. Hands-on experience with root cause analysis, product development, or R&D. Beneficial experience includes supporting complex medical devices (e.g., software, electromechanical systems) at the system level. Education: Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field). Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1
    $97.6k-152.7k yearly Auto-Apply 58d ago
  • Senior Product Quality Engineer

    Hologic 4.4company rating

    Marlborough, MA jobs

    Marlborough, MA, United States Newark, DE, United States Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a **Senior Product Quality Engineer** to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive actions to improve product performance. Collaborating with cross-functional teams, you'll contribute to product design, process improvements, and regulatory compliance while making a meaningful impact on patient safety and satisfaction. If you're a proactive problem-solver with a strong background in quality engineering, we encourage you to apply! **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). + Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). + Knowledge of root cause analysis tools and risk-based decision-making processes. + Preferred: Familiarity with test method validation, statistical methods, and standards related to reliability, electrical safety, sterilization, packaging, and biocompatibility. **Skills:** + Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues and improve product performance. + Strong data analysis and trending skills to identify patterns, assess risks, and recommend mitigations. + Ability to manage and implement design or process changes, including testing, documentation, and change control. + Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership. + Ability to collaborate with cross-functional teams, including Operations, Engineering, and R&D, to drive improvements in product design and manufacturing processes. + Preferred: Experience with statistical tools, design of experiments (DOE), and verification/validation requirements for regulated products. **Behaviors:** + Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements. + Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes. + Collaborative and team-oriented, building productive relationships across functions to drive quality improvements. + Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution. + Continuous improvement mindset, actively identifying opportunities to enhance processes and product quality. **Experience:** + Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline) required. + **5+ years** of experience with a Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering. + **1-3 years** of experience with a Master's degree, or **0-1 year** with a PhD in a related field. + Experience in an FDA-regulated industry preferred. + Hands-on experience in root cause analysis, complaint investigations, and product development or R&D is beneficial. **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. **Agency and Third-Party Recruiter Notice** _Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._ **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-NT1
    $97.6k-152.7k yearly 15d ago
  • Submit your resume for future Manufacturing and Quality roles located in RTP, NC

    Beam Therapeutics Inc. 4.0company rating

    Durham, NC jobs

    Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Beam is preparing to open a state-of-the-art Manufacturing facility located on Davis Drive in RTP, NC and will be looking for Manufacturing and Quality professionals to join our team! Please submit your resume here to be considered for positions that we will be opening in Q4 2022 and throughout 2023. We are looking for fearless innovators who are passionate about helping patients and looking to join a collaborative environment where you will be able to have a direct impact on getting our facility up and running.
    $62k-93k yearly est. 60d+ ago
  • Product Quality Engineer II

    Conformis Inc. 4.3company rating

    Wilmington, MA jobs

    The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Lead or assist with the Corrective Action/Preventive Action (CAPA) program. • Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including leading supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. • Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. • ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. • Demonstrated proficiency with FDA and ISO standards for Medical Devices. restor3d/ Conformis is an Equal Opportunity Employer
    $83k-107k yearly est. Auto-Apply 60d+ ago
  • Product Quality Engineer

    Conformis Inc. 4.3company rating

    Wilmington, MA jobs

    The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Assist with the Corrective/Preventive Action (CAPA) program. • Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d/ Conformis is an Equal Opportunity Employer
    $83k-107k yearly est. Auto-Apply 60d+ ago
  • Product Quality Engineer

    Conformis Inc. 4.3company rating

    Wilmington, MA jobs

    The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Assist with the Corrective/Preventive Action (CAPA) program. Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d is an Equal Opportunity Employer
    $83k-107k yearly est. Auto-Apply 60d+ ago
  • Product Quality Engineer

    Conformis Inc. 4.3company rating

    Wilmington, MA jobs

    The Product Quality Engineer will be responsible for product quality engineering/ quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing, continuous improvement, and product release activities. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Perform quality testing of CER and Purified water system. Perform product release activities (on an as needed basis). Administers the bioburden/endotoxin testing program as required per procedure. Trend in-process manufacturing data and environmental monitoring data and produce summary reports. Implement and maintain quality system in accordance to applicable regulatory requirements. Initiate and participate in resolution of non-conforming materials. Review Non-Conformity Reports for sub-assemblies and finished goods. Administer the calibration system. Review of the daily activities for production start-up. Develop and upgrade procedures for continuous improvement as required by the quality system. Perform Internal Quality Audits of the quality system. Develop qualification/validation plans. Conduct product/process validations (sterilization). Develop and implement statistical sampling plans. Assist in the investigation of product complaints. Assist in corrective action investigations. Perform internal audits to drive continuous improvement (minimum of 2 per year). Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering or Science. 1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred - with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications). Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office 2010. Knowledge of FDA and ISO standards for Medical Devices is a plus. Knowledge of Statgraphics or Minitab is a plus. Conformis is an Equal Opportunity Employer
    $83k-107k yearly est. Auto-Apply 60d+ ago
  • Product Quality Engineer II

    Conformis Inc. 4.3company rating

    Wilmington, MA jobs

    The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Lead or assist with the Corrective Action/Preventive Action (CAPA) program. Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including leading supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Demonstrated proficiency with FDA and ISO standards for Medical Devices. restor3d is an Equal Opportunity Employer
    $83k-107k yearly est. Auto-Apply 60d+ ago
  • Standards Engineer (Civil) II | T&D

    Aps 4.1company rating

    Valle, AZ jobs

    Arizona Public Service generates reliable, affordable and clean energy for 2.7 million Arizonans. Our service territory stretches across the state, from the border town of Douglas to the vistas of the Grand Canyon, from the solar fields of Gila Bend to the ponderosa pines of Payson. As the state's largest and longest-serving energy provider, our more than 6,000 dedicated employees power our vision of creating a sustainable energy future for Arizona. Since our founding in 1886, APS has demonstrated a strong commitment to our customers in one of the country's fastest growing states, earning a reputation for customer satisfaction, shareholder value, operational excellence and business integrity. Our present and future success depends on the creative and dedicated people of our company who demonstrate the principles outlined in the APS Promise: Design for Tomorrow, Empower Each Other and Succeed Together. Summary We are seeking a skilled and motivated T&D Standards Engineer (Civil) II/III to support the safe, reliable, and efficient construction, operation, and maintenance of our Transmission & Distribution (T&D) systems. In this role, you will apply your civil engineering expertise to moderate-scale engineering and construction projects, contributing to the development and enhancement of T&D standards and practices. Key responsibilities include creating and maintaining construction standards and material specifications, conducting engineering analyses, evaluating materials and failed components, and supporting internal design and construction teams. You'll play an active role in identifying improvement opportunities across T&D design and construction processes, and will have increasing responsibility for technical decisions, guidance, and customer engagement. The ideal candidate is detail-oriented, collaborative, and proactive in staying informed on industry trends and emerging technologies. Occasional after-hours support may be required. Minimum Requirements Engineer II A four-year Bachelors degree in an engineering discipline or related applied science discipline (see approved list) from an ABET accredited institution, an International Engineering Alliance (IEA) recognized institution or an ABET Mutual Recognition Agreement (MRA) plus two (2) years working experience in Engineering-related positions. Engineer III A four-year Bachelors degree in an engineering discipline or related applied science discipline (see approved list) from an ABET accredited institution, an International Engineering Alliance (IEA) recognized institution or an ABET Mutual Recognition Agreement (MRA) plus five (5) years working experience in Engineering-related positions. Approved Engineering degrees: Materials Science/Metallurgy, Physics, Chemistry, Nuclear, Electrical, Mechanical, Civil, Electronics, Computer Science, Environmental, Chemical, Structural. (A four-year bachelor of Engineering Technology degree is not considered an automatic equivalent for a B.S. degree in Engineering. A review of the degree program curriculum must be completed by Engineering department management.) Preferred Special Skills, Knowledge or Qualifications: Civil/Structural Engineering Degree. Experience in structural loading analysis using O-Calc or other similar software programs. Ability to apply good construction, operating and engineering practices while adhering to the APS safety rules and company policies. Good oral and written communications skills. Major Accountabilities 1) Analyzes and prepares a variety of data, technical reviews and evaluations, trend analyses, short to long-range technology assessments, products and services, investigations, product/specification verifications to aid decision making. May present findings to a diverse group of management, internal staff, customers, vendors, etc. 2) Identifies, communicates and advocates resolution of technical concerns while adhering to sound engineering principles during evaluation / resolution of the conditions. Challenges conditions and decisions when needed to ensure T&D Standards, engineering designs, project controls and oversight of work has high technical quality, is cost effective, in compliance with established standards, codes and regulations, maintains future reliability, satisfies customer requirements, budget and schedules to meet or exceed all reasonable or agreed upon customer service levels. 3) Interfaces with customers or cross organizational team members to assess their needs, determine the scope of the project, obtain necessary data to make key decisions which may require consultation with external or internal customers or employees. 4) May provide oversight of engineering technical programs by managing the program requirements, working with cross organizational partners, reviewing and internalizing operating experience and coordinating corrective actions to ensure engineering program elements continue to meet T&D standards. 5) Provides support for projects and modifications that will increase operating efficiency. May review design and documentation of projects to ensure compliance with design specifications, schedules and any regulatory requirements. 6) Plans, coordinates, sets priorities, and applies resources on moderate projects or processes. 7) Takes initiative to eliminate barriers and uses resources to ensure desired results. 8) Checks and reviews standard analysis, evaluations, and investigations of others. 9) Provides technical guidance and leadership to less experienced engineers. 10) Remains cognizant of current technology and engineering developments as well as industry and competitive developments. 11) Maintains high individual level of engineering technical capabilities and expertise by formal education, self-study, and awareness of technology advances. Export Compliance / EEO Statement This position may require access to and/or use of information subject to control under the Department of Energy's Part 810 Regulations (10 CFR Part 810), the Export Administration Regulations (EAR) (15 CFR Parts 730 through 774), or the International Traffic in Arms Regulations (ITAR) (22 CFR Chapter I, Subchapter M Part 120) (collectively, 'U.S. Export Control Laws'). Therefore, some positions may require applicants to be a U.S. person, which is defined as a U.S. Citizen, a U.S. Lawful Permanent Resident (i.e. 'Green Card Holder'), a Political Asylee, or a Refugee under the U.S. Export Control Laws. All applicants will be required to confirm their U.S. person or non-US person status. All information collected in this regard will only be used to ensure compliance with U.S. Export Control Laws, and will be used in full compliance with all applicable laws prohibiting discrimination on the basis of national origin and other factors. For positions at Palo Verde Nuclear Generating Stations (PVNGS) all openings will require applicants to be a U.S. person. Pinnacle West Capital Corporation and its subsidiaries and affiliates ('Pinnacle West') maintain a continuing policy of nondiscrimination in employment. It is our policy to provide equal opportunity in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations. This policy of nondiscrimination shall include, but not be limited to, recruiting, hiring, promoting, compensating, reassigning, demoting, transferring, laying off, recalling, terminating employment, and training for all positions without regard to race, color, religion, disability, age, national origin, gender, gender identity, sexual orientation, marital status, protected veteran status, or any other classification or characteristic protected by law. For more information on applicable equal employment regulations, please refer to EEO is the Law poster. Federal law requires all employers to verify the identity and employment eligibility of every person hired to work in the United States, refer to E-Verify poster. View the employee rights and responsibilities under the Family and Medical Leave Act (FMLA). In compliance with the Drug Free Workplace Act of 1988, the Company is committed to a work environment that is free from the effects of alcohol and controlled substances, and free from the abuse or inappropriate use of prescribed and over-the-counter medications. The Company requires employees to be subject to drug and alcohol testing that is job-related and consistent with business necessity, regulatory requirements and applicable laws. Hybrid: Employees in hybrid roles work both in their home offices (virtually) and alongside their colleagues (in person). In order for employees to build strong relationships and to promote meaningful in-person interactions, hybrid employees are expected to work about 40% of their time in-person at an APS or other (non-home office) location. *Employees are expected to reside in Arizona (or New Mexico for Four Corners-based employees). *Working from a home office requires adequate technology and an appropriate ergonomic set up. *Role types are subject to change based on business need
    $75k-104k yearly est. 60d+ ago

Learn more about Teleflex jobs