Senior Quality Manager jobs at Regeneron - 1384 jobs
Director, Vendor and Partners Quality Management
Rigel Pharmaceuticals Inc. 4.2
San Francisco, CA jobs
The Director, Vendors and Partners Quality Management provides strategic and operational oversight of Rigel's external quality network, including global commercial partners and GxP vendors. This role ensures quality and compliance alignment with partners who hold Marketing Authorizations for Rigel's products outside the USA and drives quality and compliance with Rigel vendors supplying GxP materials or services. The Director is responsible for managing quality agreements, engaging in partner and vendor audits, and the exchange of quality documentation to support regulatory filings and inspections.
Salary Range: $210,000 to $250,000
ESSENTIAL DUTIES AND RESPONSIBILITIES
Establish, maintain, and manage Quality Agreements with partners and vendors to ensure clear GxP responsibilities.
Lead the vendor quality management program through select-implement-manage-decommission lifecycle across GMP, GCP, and GLP areas.
Manage partner complaint investigations and ensure compliant communication and documentation closure.
Oversee vendor and partner audits, including scheduling, conduct, reporting, and follow-up actions.
Coordinate exchange of quality documents with partners to support regulatory submissions and inspections.
Lead Rigel Change Management program for clinical and commercial products, applying phase-appropriate and risk-based framework and ensuring compliance with regulatory requirements.
Serve as a Quality lead for Rigel Technology Transfer projects.
Provide Quality support for assessment and implementation of new assets.
Develop and maintain metrics (KPIs) to monitor vendor and partner quality performance.
Collaborate with Regulatory, Legal, and Supply Chain to ensure partners and vendors meet contractual and regulatory obligations.
Provide QA input into business development and alliance management processes.
Stay current with global regulatory expectations impacting partner and vendor oversight programs.
Represent Rigel Quality in governance meetings with external partners and key suppliers.
KNOWLEDGE AND SKILL REQUIREMENTS
Bachelor's degree in life sciences or related discipline; advanced degree preferred.
12+ years of pharmaceutical Quality Assurance experience, including vendor and partner management.
Strong understanding of global GxP regulations and supplier quality requirements.
Experience leading audits and managing external Quality Agreements.
Knowledge of both commercial and clinical product quality systems and regulatory submissions.
Exceptional interpersonal skills for effective collaboration with external partners and cross-functional stakeholders.
Ability to travel domestically and internationally for audits and partner meetings.
WORKING CONDITIONS
PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
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$210k-250k yearly 2d ago
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Director of Patient Safety and Quality
Kaweah Health 4.0
Visalia, CA jobs
We are excited to present an opportunity for a Director of Patient Safety and Quality at Kaweah Health, a publicly owned, community healthcare organization in Visalia, California. With over 5,000 employees and an eight-campus healthcare district encompassing 613 beds, Kaweah Health delivers comprehensive health services across a broad continuum of care. Our culture is deeply rooted in responsibility and accountability, emphasizing ownership from our team members. We serve a region with significant needs, making the rewards of contributing to our mission even greater.
Company Overview: Kaweah Health is dedicated to providing state-of-the-art medicine and high-quality preventive services, focusing on making a tangible difference in the health of our patients, loved ones, and community. Dr. Stefanacci, your direct report, fosters a supportive environment with minimal interference.
Position Overview: The Director of Quality orchestrates and influences the work of others to enhance Kaweah Health's mission, vision, and strategic priorities. This high-level leadership role holds accountability for safety and the necessary infrastructures to meet patient and family expectations. You will be instrumental in setting and executing strategies related to quality, patient safety, and regulatory compliance for a billion-dollar health system, impacting a large patient population in the Central Valley.
Primary Responsibilities: The Director of Quality will be responsible for quality, patient safety, and regulatory compliance. This involves collaborating with Dr. Stefanacci CMO/CQO, to set priorities and strategies, and then executing these plans effectively.
The role supports performance improvement activities throughout the organization, providing essential project management, performance improvement, and data analytics support. You will also be responsible for presenting to the CEO, executive team, and the board, and overseeing the quality of care for our extensive patient population.
This position designs and orchestrates the implementation of Quality and Patient Safety Plans, identifies and implements appropriate methods and tools for quality and patient safety, and participates in case review committees to address sentinel events and significant near misses. You will also provide resources for measurement and evaluation, collaborate with medical staff leaders on quality and patient safety systems, and develop a skilled department staff.
Coordinating all Joint Commission accreditation surveys and preparations is a key responsibility, as is identifying and implementing strategies for safety culture improvement and providing professional development opportunities.
Key Qualifications and Skills: We are seeking a candidate with 10 or so years of experience in quality-related roles within a hospital or health system, with at least 5 years of experience as a leader of a department or quality team. Expertise in performance improvement and experience managing people and a department are essential. The ideal candidate will have a proven track record of responsibility for strategic initiatives with demonstrated positive outcomes, showcasing an impact on strategic priorities with measurable results.
Strong collaboration skills are crucial for engaging teams and physicians. A passion for quality and patient safety, coupled with resilience, is highly valued due to the challenges inherent in this role. Required certifications include a current license in a relevant clinical discipline and a Certified Professional in Health Care Quality (CPHQ). Formal training in project management or performance improvement, such as Black Belt or Six Sigma certification, is also required. A Bachelor's degree in Health Care Administration, Nursing, or a relevant clinical discipline with additional training in Quality and Patient Safety is necessary, with a Master's degree preferred.
Team and Reporting Structure: This role reports directly to Dr. Stefanacci, who is the Chief Medical Officer and Chief Quality Officer. The Director of Quality will lead a diverse team comprising a quality team (manager + 5 individuals), an accreditation team (manager + 2 individuals), two data analytics specialists, two project management and performance improvement specialists, a patient safety program manager, and individuals overseeing stroke, sepsis, and clinical practice guidelines programs.
Collaboration is essential with the CEO, executive team, board members, and various internal teams, including Infection Prevention, Quality, Accreditation, Data Analytics, Project Management, Patient Safety, Stroke, Sepsis, and Clinical Practice Guidelines, as well as with physicians.
Key Priorities in the First Six Months: The top priorities for the first six months include demonstrating a measurable impact on strategic priorities by articulating them, establishing benchmarks, and achieving measurable outcomes. You will also support performance improvement activities across the organization, providing essential project management, performance improvement, and data analytics support.
Challenges and Opportunities: This role presents exciting opportunities to be in a leadership position with significant responsibility for setting quality and patient safety strategy for a billion-dollar health system, with direct contact with the executive team and board. You will have the chance to impact healthcare for a very large patient population in the Central Valley. Challenges include engaging teams outside of quality to collaborate on performance improvement and gaining active physician participation.
Candidate Profile: We are looking for individuals with a passion for quality and patient safety, and strong resilience to navigate barriers and roadblocks. Experience at a director level in a hospital or health system quality program, expertise in performance improvement, and experience managing a department or quality team are highly advantageous.
A clinical background is considered very helpful. Candidates should demonstrate ownership and responsibility for programs with measurable outcomes, beyond just achieving high ratings. Experience and responsibility for regulatory and accreditation are also necessary.
Candidates who thrive in community-based organizations with limited support are encouraged to apply.
We are actively seeking to fill this critical position and encourage you to apply if you meet these qualifications and are passionate about making a significant impact on healthcare quality and patient safety.
Mike Duggan is running the search, if you would like to learn more he can be reached at ************ or *****************************
$159k-205k yearly est. 1d ago
Director of Partner & Vendor Quality Management
Rigel Pharmaceuticals Inc. 4.2
San Francisco, CA jobs
A leading pharmaceuticals company based in San Francisco is seeking a Director of Vendor and Partners Quality Management. The role involves strategic oversight of quality compliance with external partners and vendors, managing quality agreements, and overseeing audits. The ideal candidate has over 12 years of experience in pharmaceutical Quality Assurance and must possess strong interpersonal skills for effective collaboration. This position requires a Bachelor's degree in life sciences, with an advanced degree preferred.
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$115k-153k yearly est. 2d ago
Manager - Clinical Quality Improvement
Lakeland Regional Health-Florida 4.5
Lakeland, FL jobs
Details
Lakeland Regional Health is a leading medical center located in Central Florida. With a legacy spanning over a century, we have been dedicated to serving our community with excellence in healthcare. As the only Level 2 Trauma center for Polk, Highlands, and Hardee counties, and the second busiest Emergency Department in the US, we are committed to providing high-quality care to our diverse patient population. Our facility is licensed for 910 beds and handles over 200,000 emergency room visits annually, along with 49,000 inpatient admissions, 21,000 surgical cases, 4,000 births, and 101,000 outpatient visits.
Lakeland Regional Health is currently seeking motivated individuals to join our team in various entry-level positions. Whether you're starting your career in healthcare or seeking new opportunities to make a difference, we have roles available across our primary and specialty clinics, urgent care centers, and upcoming standalone Emergency Department. With over 7,000 employees, Lakeland Regional Health offers a supportive work environment where you can thrive and grow professionally.
Active - Benefit Eligible and Accrues Time Off
Work Hours per Biweekly Pay Period: 80.00
Shift: Flexible Hours and/or Flexible Schedule
Location: 1324 Lakeland Hills Blvd Lakeland, FL
Pay Rate: Min $89,523.20 Mid $111,904.00
Position Summary
The Manager - Clinical Quality is a health care professional that works to improve patient care, safety, and outcomes, and works to make policy and process improvements to promote the safest, evidence-based care. In this role the team member will focus on quality improvement and healthcare initiatives that drive major changes. Clinical Quality is at the forefront of innovation and change in the healthcare system. The Manager is responsible for planning, implementing, and evaluating a quality program to improve patient outcomes and maintain cost-effective healthcare. Under the leadership of the Senior Director of Quality and Performance Improvement, this position collaborates with multiple departments to promote and inspire a culture of quality and safety.
Position Responsibilities
People At The Heart Of All We Do
Fosters an inclusive and engaged environment through teamwork and collaboration.
Ensures patients and families have the best possible experiences across the continuum of care.
Communicates appropriately with patients, families, team members, and our community in a manner that treasures all people as uniquely created.
Safety And Performance Improvement
Behaves in a mindful manner focused on self, patient, visitor, and team safety.
Demonstrates accountability and commitment to quality work.
Participates actively in process improvement and adoption of standard work.
Stewardship
Demonstrates responsible use of LRH's resources including people, finances, equipment and facilities.
Knows and adheres to organizational and department policies and procedures.
Standard Work: Manager - Clinical Quality
Researches, develops and facilitates quality improvement initiatives leading to efficient processes and standard work based on evidenced based practices in collaboration with operations clinical experts/leaders and physicians.
Ensures that data-driven performance management and quality improvement programs are designed and implemented in a manner that aligns with an organization's overall strategy.
Supervises the Clinical Quality and Vascular Access departments within the Quality Division.
Establishes and coordinates the collection, analysis, and presentation of data for all quality measures.
Effectively communicates this information, as well as the strategic vision, scope and mission of Clinical Quality.
Collaborates with informatics to ensure technology infrastructure can support quality improvement programs.
Competencies & Skills
Essential:
Effective Interpersonal Skills.
Working knowledge of quality management and process improvement applications and knowledge of clinical processes
Strong written and verbal communication skills.
Nonessential:
Demonstrates knowledge of process control statistics and advanced data analysis techniques.
Qualifications & Experience
Essential:
Bachelor Degree
Experience Essential:
Five years clinical healthcare experience
Experience Preferred:
Quality Professional (clinical patient safety, quality or accreditation role)
Two to three years of experience with increasing leadership responsibility
Certifications Essential:
CPHQ Certification within 2 years of hire
CPPS Certification
CAPM or PMP
Licenses Essential:
Current RN or Healthcare License in the state of Florida
$89.5k-111.9k yearly 5d ago
Director of Quality and Risk Management
Vibra Healthcare 4.4
Massachusetts jobs
COME BUILD YOUR CAREER WITH VIBRA HEALTHCARE!
We are seeking a Director of Quality / Risk Management to join our team!
Responsibilities
Responsible for directing quality management efforts to ensure continuous improvement and organizational excellence, adherence with all regulatory, compliance, accreditation, and legal issues, and promote a safe environment for all employees, patients and visitors. Manage risk issues and oversees the credentialing function for medical staff. Accountable for the development, management and coordination of the hospital-wide Performance Improvement Program designed to improve clinical outcomes and the patient experience. Responsible for maintaining compliance with CMS Conditions of Participation, the Joint Commission standards, COLA/CLIA standards and HIPAA Rules and Regulations. Functions as the Risk Manager for organization as well as the Facility Compliance Officer.
Required Skills:
An active clinical license in the state of employment is required in one of the following fields: Nursing, Physical Therapy, Occupational Therapy, Speech Language Pathology or Respiratory Therapy.
Minimum three (3) years of work experience or equivalent, in quality/risk management activities required.
Knowledgeable in the principles of performance improvement.
Additional Qualifications/Skills:
Bachelor's or Master's degree preferred. Management experience preferred.
Certified Professional Healthcare Quality (CPHQ) certification preferred.
Possess in-depth knowledge of functions of all hospital departments and quality improvement requirements as outlined by the Joint Commission, the state of employment's Department of Health and Federal regulatory standards as outlined by CMS.
Experience in interpretation of raw data and comparative analysis, experience in conducting educational in- services, experience in coordinating and supervising accreditation/certification survey activities for the Joint Commission, CMS, State Licensure and demonstrated experience in working effectively with multiple departments on confidential issues in a positive and constructive manner.
Experience in Risk Management systems and experience in working with the public on issues related to satisfaction/complaints required.
Ability to project a professional image.
Knowledge of regulatory standards and compliance requirements.
Strong organizational, prioritizing and analytical skills.
Ability to make independent decisions when circumstances warrant.
Working knowledge of computer and software applications used in job functions.
Freedom from illegal use of and effects of use of drugs and alcohol in the workplace.
Qualifications
At Vibra Healthcare, employees are our priority. We are passionate about patient care and consider it a privilege to be able to provide services to patients and their family members. Below is a brief summary of our benefits.
• Medical PPO high and low deductible plans / HSA options as well as HMO options in some markets
• FREE prescription plans
• Dental and Vision coverage
• Life insurance
• Disability Benefits
• Employee Assistance Plan
• Flex Spending plans, 401K matching
• Additional Critical Illness, Accident, and Hospital plans
• Company discounts for mobile phone service, electronics, cell phones, clothing, etc
• Pet Insurance
• Group legal - provides legal assistance with personal legal matters
• Tuition and continuing education reimbursement
• Work life balance
At Vibra Healthcare, our patients are family. Healthcare is constantly evolving, our growing organization is devoted to ensuring that each person in our care feels safe. Our world-class team of driven, passionate healthcare professionals are always focused on service excellence and providing top quality care at the bedside. Our culture fosters engagement, diversity and advocacy. Our goal is to empower our employees and support them in their professional growth while leading them on a path to success within our organization.
Posted Salary Range
USD $50.00 - USD $60.00 /Hr.
$50-60 hourly 18h ago
Global Quality Policy & Advocacy Leader
Gilead Sciences, Inc. 4.5
Washington, DC jobs
A leading biopharmaceutical company is seeking a Senior Director of Quality Policy and Advocacy to lead global policy initiatives. This role requires extensive experience in Quality strategies, particularly within North American regulatory landscapes. You will be responsible for advocating Gilead's portfolio interests and engaging with stakeholders to resolve complex Quality issues. The ideal candidate will have a strong background in regulatory affairs, leadership skills, and the ability to communicate effectively with diverse audiences. This role offers a competitive salary and benefits.
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$91k-117k yearly est. 3d ago
Director, R&D Quality Governance & Risk
Vertex Pharmaceuticals 4.6
Boston, MA jobs
A global biotechnology company is seeking a Director of R&D Quality Governance & Risk Management to lead and enhance the governance framework supporting risk-based decisions. This strategic role requires 10+ years of R&D QA experience, strong leadership presence, and operational agility. Candidates should possess exceptional collaboration skills and mentorship capabilities. The role offers flexibility in a hybrid work environment with competitive compensation and comprehensive benefits.
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$141k-181k yearly est. 1d ago
Clinical Quality Coordinator
St. John's Riverside Hospital 4.7
Yonkers, NY jobs
The Quality Registered Nurse plays a vital role in advancing the hospital ' s journey toward the ANCC Pathway to Excellence designation. This position supports the development of a positive practice environment by leading quality improvement initiatives, promoting nursing excellence, and ensuring alignment with the six Pathway Standards: Shared Decision-Making, Leadership, Safety, Quality, Well-Being, and Professional Development.
Lead and coordinate quality improvement projects that align with Pathway standards, focusing on patient safety, clinical outcomes, and nursing practice.
Support shared governance structures by facilitating nurse-led councils and promoting frontline nurse involvement in decision-making.
Monitor and report on nursing-sensitive indicators, including infection rates, falls, medication errors, and readmissions.
Conduct audits and root cause analyses to identify opportunities for improvement and ensure compliance with evidence-based practices.
Collaborate with nursing leadership to develop and implement strategies that foster a respectful, safe, and empowering work environment.
Educate staff on Pathway standards, quality initiatives, and professional development opportunities.
Assist in preparing documentation for the Pathway application, including narratives, outcome data, and survey coordination.
Promote nurse well-being by supporting initiatives that address physical and mental health, recognition, and work-life balance.
How This Role Supports Pathway to Excellence:
The Pathway to Excellence designation requires hospitals to demonstrate excellence across six standards: [*********************
Shared Decision-Making - Quality Nurses help facilitate nurse-led councils and shared governance.
Leadership - They collaborate with nurse leaders to promote transparency, accountability, and mentorship.
Safety - They lead initiatives to reduce harm and foster a respectful workplace.
Quality - They monitor outcomes and drive continuous improvement.
Well-Being - They support programs that promote nurse wellness and recognition.
Professional Development - They help create learning opportunities and career advancement pathways.
Requirements
Bachelor's degree in Nursing (BSN) required, Master's preferred
Minimum of 3-5 years of clinical experience in a hospital setting.
Experience in quality improvement, patient safety, or nursing excellence programs preferred.
Familiarity with ANCC Pathway to Excellence standards and survey process.
Strong analytical, communication, and project management skills.
Proficiency in data analysis tools and electronic health records.
Registered Nurse (RN) with active New York State licensure.
$47k-74k yearly est. 4d ago
Principal Engineer, AI-Driven QC & Data Consumption
Vertex Pharmaceuticals (San Diego) LLC 4.6
Boston, MA jobs
A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package.
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$105k-132k yearly est. 2d ago
Manager, Quality and Manufacturing
Hello Heart 3.9
Remote
Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information.
About the Role:
As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production.
Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes.
Responsibilities
Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation
Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones
Create and maintain quality control plans across IQC, IPQC, and OQC processes
Define and implement manufacturing process controls, test requirements, and build validation plan
Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies
Drive corrective and preventive actions and verify long-term effectiveness
Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health
Monitor yields, reduce defects, and drive continuous improvement across production lines
Assess supplier capability and lead onsite production reviews and factory evaluations
Define incoming inspection criteria, sampling plans, and supplier quality alignment
Maintain detailed build documentation, quality dashboards, and audit reports
Qualifications
7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline
Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes
Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma
Proven experience leading root cause analysis and driving corrective actions
Experience working with contract manufacturers and suppliers, preferably in Asia
Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data
Excellent communication skills with the ability to present findings and recommendations
Experience supporting NPI builds and high-volume product ramp is preferred
Familiarity with reliability testing and environmental qualification is preferred
Knowledge of hardware system integration spanning mechanical and electrical components is preferred
Experience with DOE, process optimization, or Lean Manufacturing is preferred
Mandarin language proficiency is a plus
The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits.
Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.
$140k-160k yearly Auto-Apply 40d ago
Director of Quality
Joseph P. Addabbo Family Health Center 4.7
Malverne, NY jobs
The Director of Quality is responsible for developing, implementing, and maintaining a comprehensive quality improvement (QI) and performance management program for the Federally Qualified Health Center (FQHC). This role ensures compliance with HRSA requirements, NCQA Patient-Centered Medical Home (PCMH) standards, UDS reporting, and other regulatory or accreditation bodies, while fostering a culture of continuous improvement in clinical, operational, and patient experience outcomes.
RESPONSIBILITIES:
* Directly supervises the Quality Coordinators.
* Develops Quality Assurance policies to ensure successful implementation of improvement standards.
* Serves as the primary liaison between JPA and Managed Care Organizations (MCOs), representing the organization in all quality-related engagements and ensuring active participation in MCO quality meetings. Assesses patient medical records to ensure compliance with established quality standards.
* Coordinates and ensures timely completion of the quarterly provider peer review cycle.
* Conduct on-site visits to monitor and assess the implementation of QA/QI activities, including pre-visit planning and daily huddles.
* Aggregates statistical quality assurance data, develops comprehensive narrative reports, and partners with clinical informatics specialists to support data-driven improvements.
* Collaborates with the CMO to revise the Quality Assurance and Utilization Review plan in accordance with HRSA guidelines.
* Coordinates recurring QI/QA meetings with the Quality Coordinators and Department Leads, manages meeting coordination, records minutes, tracks participation, and ensures timely follow-up on all assigned tasks and activities.
* Monitor and track performance on HEDIS and other quality measures across payer contracts.
* Identify and prioritize care gaps in collaboration with clinical and operational teams.
* Develop and implement strategies to close care gaps, including outreach campaigns, provider engagement, and patient education.
* Collaborate with clinical teams, payors, and population health staff to align quality improvement efforts with value-based care goals. Maintain up-to-date knowledge of CMS, NCQA, and payer-specific quality measure requirements.
* Assist in the reporting and analysis of quality metrics to identify trends, disparities, and opportunities for improvement.
* Coordinate with IT and analytics teams to ensure accurate and timely data capture and reporting.
* Support the preparation of documentation and evidence for HEDIS audits and external reviews.
* Contribute to quality improvement initiatives, such as PDSA cycles, root cause analyses, and performance dashboards.
* May be required to perform other duties as assigned or when necessary.
QUALIFICATIONS:
Education:
* Bachelor's degree in healthcare administration, public health, Nursing, or related field required.
* Master's degree in public health, Healthcare Administration, or related field preferred.
* A licensed Registered Nurse (RN) or Nurse Practitioner (NP) with a strong background in healthcare quality improvement will also be considered in lieu of a master's degree.
Experience:
* Minimum 5 years of progressively responsible experience in healthcare quality or performance improvement, preferably in a community health center or FQHC setting.
* Strong working knowledge of HRSA, UDS, NCQA PCMH, and related regulatory requirements.
Skills:
* Demonstrated ability to lead quality initiatives and manage cross-functional teams.
* Proficiency in data analysis and quality improvement tools (e.g., Excel, EHR reporting, QI methodologies). Excellent verbal and written communication skills.
* Experience with risk management, clinical compliance, and patient safety programs is a plus.
Working Conditions:
* Primarily office-based with some travel between clinical sites.
* May require occasional evenings or weekends for meetings or training.
Why Join Us: Be part of a mission-driven organization focused on improving patient outcomes and advancing health equity. Collaborate with cross-functional teams to shape the future of value-based care. Opportunities for growth and professional development in a dynamic healthcare environment.
$110k-139k yearly est. 19d ago
Director, Regulatory Affairs and Quality Assurance
Whoop 4.0
Boston, MA jobs
WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Director of Regulatory Affairs & Quality Assurance (RA/QA), you will lead the strategy, execution, and continuous evolution of WHOOP's regulatory and quality frameworks as we expand deeper into regulated digital health and medical-grade product capabilities. You will also play a critical role in strengthening WHOOP's design quality discipline, ensuring robust design controls, risk management, and design quality practices. You will shape the regulatory pathway for our next generation of health features, ensure compliance across global markets, and build systems that enable WHOOP to scale medical device development responsibly and efficiently.
This role is ideal for a seasoned RA/QA leader who thrives in fast-paced, cross-functional environments and is motivated by the opportunity to help define the future of WHOOP as a health technology company.QUALIFICATIONS:
Lead regulatory strategy for WHOOP's health features and regulated products from development through approval and lifecycle management.
Oversee regulatory submissions including 510(k), De Novo, technical files, global registrations, providing strategic direction, final review, and cross-functional alignment.
Serve as WHOOP's primary liaison with regulatory agencies and notified bodies.
Interpret and communicate regulatory requirements to cross-functional teams, ensuring seamless integration throughout the development lifecycle.
Oversee WHOOP's Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDR, and other global regulatory frameworks.
Provide leadership and oversight for Design Quality Engineers responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software change control processes.
Lead internal and external audit readiness, including FDA inspections and notified body audits.
Manage post-market surveillance and adverse event reporting.
Review marketing and promotional materials for regulated and general wellness features to ensure compliance.
Build, manage, and mentor a high-performing team.
Monitor regulatory changes, evolving standards, and industry trends, advising leadership on implications and opportunities.
RESPONSIBILITIES:
Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred.
8+ years of regulatory affairs experience in medical devices, digital health, wearables, or related fields.
Proven experience leading successful FDA submissions (510(k), De Novo) and managing global regulatory approvals.
Demonstrated success building or overseeing a Quality Management System, including experience with external audits.
Deep understanding of software as a medical device (SaMD), cybersecurity considerations, post-market requirements, and applicable standards.
Strong working knowledge of ISO 14971 risk management, including hazard analysis, FMEAs, risk/benefit justification, and integration of risk controls across hardware, firmware, and software.
Experience overseeing post-market quality activities, including complaints, MDR/Vigilance assessments, field actions, and design updates based on post-market signals.
Working knowledge of privacy and data regulations such as HIPAA and GDPR.
Exceptional communication, leadership, and stakeholder management skills.
Ability to thrive in a fast-paced, high-growth environment with evolving priorities.
Experience navigating the boundary between general wellness and SaMD, including evaluating feature intent, regulatory risk, and appropriate evidence pathways.
It is strongly preferred that the candidate is able to work out of the WHOOP office located in Boston, MA.
Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
WHOOP is an Equal Opportunity Employer and participates in
E-verify
to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.
At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
The U.S. base salary range for this full-time position is $220,000-$245,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.
In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.
These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements.
Learn more about
WHOOP
.
$220k-245k yearly Auto-Apply 54d ago
Manager, Quality and Manufacturing
Hello Heart 3.9
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 38d ago
RN Quality Program Manager - Oncology
Providence Health & Services 4.2
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 39d ago
RN Quality Program Manager - Oncology
Providence Health and Services 4.2
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 2d ago
Program Manager Sepsis - Quality Systems Improvement
Penn State Health 4.7
Hershey, PA jobs
**Penn State Health** - **Hershey Medical Center** **Work Type:** Full Time **FTE:** 1.00 **Shift:** Day **Hours:** 40 hours **Recruiter Contact:** Taryn Blydenburgh at ************************************ (MAILTO://************************************)
**SUMMARY OF POSITION:**
Responsible to oversee, prioritize, and direct the planning and execution of clinical quality improvement activities for the sepsis population hospital-wide, achieving targeted quality, safety, and financial objectives. Leads performance improvement initiatives through application of clinical expertise, knowledge of both clinical and administrative settings and frequent interactions with a variety of clinical and non-clinical roles. Facilitates the bedside clinical care of sepsis to assure that all patients receive comprehensive and timely treatment interventions that are consistent with best practice recommendations. Participates in program development as it relates to sepsis care. Functions as an educator, and collects and analyzes data surrounding sepsis patients to assist with documentation, coding, clinical care, and outcomes related to key leading indicators. This position collaborates with interdisciplinary teams to develop and/or identify evidence based practices and to establish standards in support of clinical quality outcome program goals.
**MINIMUM QUALIFICATIONS:**
+ Bachelor's degree in Nursing required.
+ Currently licensed to practice as a Registered Nurse by state of employment or holds a multistate RN license through the interstate Nurse Licensure Compact.
+ 5 years of acute care clinical experience required.Previous experience with developing clinical practice recommendations supported by current literature required.
+ Previous experience leading quality initiatives, culture transformation, and performance improvement efforts required.
**PREFERRED QUALIFICATIONS:**
+ Master's degree in Nursing preferred.
+ Lean Six Sigma, project management, root cause analysis certification or equivalent training preferred.
**WHY PENN STATE HEALTH?**
Penn State Health offers exceptional opportunities to learn and grow, exposure to a wide patient population, and the ability to provide individualized, innovative, and specialized care to patients in the community.
**Penn State Health offers an exceptional benefits package including medical, dental and vision with no waiting period as well as a Total Rewards Program that highlights a few of the many additional offerings below:**
+ **_Be Well_** with Employee Wellness Programs, and Fitness Discounts (University Fitness Center, Peloton).
+ **_Be Balanced_** with Generous Paid Time Off, Personal Time, and Paid Parental Leave.
+ **_Be Secured_** with Retirement, Extended Illness Bank, Life Insurance, and Identity Theft Protection.
+ **_Be Rewarded_** with Competitive Pay, Tuition Reimbursement, and PAWS UP employee recognition program.
+ **_Be Supported_** by the HR Solution Center, Learning and Organizational Development and Virtual Benefits Orientation, Employee Exclusive Concierge Service for scheduling.
**WHY PENN STATE HEALTH MILTON HERSHEY MEDICAL CENTER?**
Penn State Hershey Medical Center is Central Pennsylvania's only Academic Medical Center, Level 1 Regional Adult and Pediatric Trauma Center, and Tertiary Care Provider. As a four-time Magnet-designated hospital, Hershey Medical Center values the hard work and dedication that our employees exhibit every day. Through our core values of Respect, Integrity, Teamwork, and Excellence, our employees are a team committed to compassionate care for our diverse patient population, our community and each other. As a valued team member, we promote continued professional development, specialty certification, continuing education, and career growth.
**YOU TAKE CARE OF THEM. WE'LL TAKE CARE OF YOU. State-of-the-art equipment, endless learning, and a culture of excellence - that's Penn State Health. But what makes our healthcare award-winning? That's all you.**
_This job posting is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. Eligibility for shift differential pay based on the terms outlined in company policy or union contract._ _All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities._
_Penn State Health is an Equal Opportunity Employer and does not discriminate on the basis of any protected class including disability or veteran status. Penn State Health's policies and objectives are in direct compliance with all federal and state constitutional provisions, laws, regulations, guidelines, and executive orders that prohibit or outlaw discrimination._
**Union:** Non Bargained
**Position** Program Manager Sepsis - Quality Systems Improvement
**Location** US:PA: Hershey | Nursing | Full Time
**Req ID** 89386
$84k-117k yearly est. Easy Apply 12d ago
Program Manager - Process Improvement - Quality Systems Improvement
Penn State Health 4.7
Hershey, PA jobs
**Penn State Health** - **Hershey Medical Center** **Work Type:** Full Time **FTE:** 1.00 **Shift:** Day **Hours:** 40 hours **Recruiter Contact:** Elyse Hahn at ****************************** (MAILTO://******************************)
**SUMMARY OF POSITION:**
The Program Manager - Process Improvement is responsible for leading strategic initiatives that enhance operational efficiency, quality, and performance across the organization. The Program Manager will oversee multiple projects simultaneously, applying structured methodologies to deliver measurable results. This role partners with cross-functional teams to identify improvement opportunities, implement best practices, and ensure alignment with organizational goals. The Program Manager will also support leading, implementing and optimizing pay for value-based programs to include the following:
+ Hospital Value-Based Purchasing (VBP) Program
+ Hospital Readmission Reduction Program (HRRP)
+ Value Modifier (VM) Program (also called the Physician Value-Based Modifier or PVBM)
+ Hospital Acquired Conditions (HAC) Reduction Program
+ Highmark Quality Blue, Aetna and Capital Blue quality measures
To be considered for this position, candidates must have experience in a similar role, or they must possess significant knowledge, experience, and abilities to successfully perform the responsibilities listed.
**MINIMUM QUALIFICATION(S):**
+ Bachelor's degree in Nursing
+ Three (3) years of nursing experience
+ Currently licensed to practice as a registered nurse by state of employment or holds a multistate RN license through the interstate Nurse Licensure Compact
+ Four (4) years of project management experience, quality improvement skills, Lean, PDSA
**PREFERRED QUALIFICATION(S):**
+ PMP
+ CPHQ
+ One (1) year of experience working in a highly matrixed, mission-driven organization.
**WHY PENN STATE HEALTH?**
Penn State Health offers exceptional opportunities to learn and grow, exposure to a wide patient population, and the ability to provide individualized, innovative, and specialized care to patients in the community.
**Penn State Health offers an exceptional benefits package including medical, dental and vision with no waiting period as well as a Total Rewards Program that highlights a few of the many additional offerings below:**
+ **_Be Well_** with Employee Wellness Programs, and Fitness Discounts (University Fitness Center, Peloton).
+ **_Be Balanced_** with Generous Paid Time Off, Personal Time, and Paid Parental Leave.
+ **_Be Secured_** with Retirement, Extended Illness Bank, Life Insurance, and Identity Theft Protection.
+ **_Be Rewarded_** with Competitive Pay, Tuition Reimbursement, and PAWS UP employee recognition program.
+ **_Be Supported_** by the HR Solution Center, Learning and Organizational Development and Virtual Benefits Orientation, Employee Exclusive Concierge Service for scheduling.
**WHY PENN STATE HEALTH MILTON HERSHEY MEDICAL CENTER?**
Penn State Hershey Medical Center is Central Pennsylvania's only Academic Medical Center, Level 1 Regional Adult and Pediatric Trauma Center, and Tertiary Care Provider. As a four-time Magnet-designated hospital, Hershey Medical Center values the hard work and dedication that our employees exhibit every day. Through our core values of Respect, Integrity, Teamwork, and Excellence, our employees are a team committed to compassionate care for our diverse patient population, our community and each other. As a valued team member, we promote continued professional development, specialty certification, continuing education, and career growth.
**YOU TAKE CARE OF THEM. WE'LL TAKE CARE OF YOU. State-of-the-art equipment, endless learning, and a culture of excellence - that's Penn State Health. But what makes our healthcare award-winning? That's all you.**
_This job posting is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. Eligibility for shift differential pay based on the terms outlined in company policy or union contract._ _All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities._
_Penn State Health is an Equal Opportunity Employer and does not discriminate on the basis of any protected class including disability or veteran status. Penn State Health's policies and objectives are in direct compliance with all federal and state constitutional provisions, laws, regulations, guidelines, and executive orders that prohibit or outlaw discrimination._
**Union:** Non Bargained
**Position** Program Manager - Process Improvement - Quality Systems Improvement
**Location** US:PA: Hershey | Nursing | Full Time
**Req ID** 88344
$84k-117k yearly est. Easy Apply 12d ago
Nursing Program Manager: Quality & Accreditation - Cancer Care Center (Galveston)
UTMB Health 4.4
Galveston, TX jobs
Minimum Qualifications\:
Bachelor's degree in nursing and current licensure or valid permit to practice professional nursing in Texas is required.
The equivalent of four years RN experience, including two years progressive management experience is required.
Approved specialty certification required, as applicable to assigned program(s)/project(s).
Job Summary:
The Program Manager is accountable for the effective strategic planning, and the personnel, operational, and financial management of assigned program(s) and/or project(s), that cross multiple departments and/or services, to ensure optimal quality, cost, and service/outcomes.
Preferred Qualifications:
Experience leading, coordinating, or supporting accreditation, regulatory compliance, and site visits, including but not limited to the American College of Radiology (ACR), Commission on Cancer (CoC), and National Accreditation Program for Breast Centers (NAPBC).
Demonstrated knowledge of quality standards, performance improvement methodologies, and regulatory requirements applicable to oncology and cancer care programs.
Experience with data abstraction, reporting, and performance metrics required for accreditation and quality oversight.
Job Duties:
Assumes a leadership role in effective strategic planning for the program(s)/project(s), incorporating quality, accreditation, and regulatory requirements into program goals and initiatives.
Directs the operational management of the program(s)/project(s) to ensure high quality, cost-effective service/outcomes, and a safe and efficient work environment, consistent with accreditation and regulatory standards.
Provides leadership and oversight for accreditation readiness, maintenance, and re-accreditation activities, including coordination of site visits, audits, documentation, and corrective action plans as needed.
Ensures ongoing compliance with applicable accreditation, regulatory, and quality standards through monitoring, reporting, and continuous improvement efforts.
Directs the personnel management of the employees assigned to the program(s)/project(s) consistent with state and federal labor laws, nursing service and hospital philosophy, goals, and policy.
Directs the financial management of the program(s)/project(s) to ensure desired fiscal status while supporting quality, compliance, and accreditation-related initiatives.
Leads and directs quality improvement activities for the program(s)/project(s), including analysis of outcomes, performance metrics, and patient experience data, and supports nursing research within the program and at the department and service level.
Collaborates with interdisciplinary teams, physicians, quality departments, and leadership to ensure alignment with organizational quality and accreditation goals.
Identifies appropriate internal controls for the department; provides mechanisms to monitor and enforce compliance with quality, accreditation, and regulatory standards.
Promotes and practices patient/family advocacy and facilitates the maintenance of ethical practice.
Promotes and practices guest and peer relations.
Demonstrates a high level of productivity and dependability.
Provides leadership for the program(s)/project(s) and promotes teamwork.
Actively promotes the professional development of self and others.
Performs related duties as required.
Salary Range:
Actual salary commensurate with experience
Equal Employment Opportunity
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.
$83k-108k yearly est. Auto-Apply 60d+ ago
Nursing Program Manager: Quality & Accreditation - Cancer Care Center (Galveston)
UTMB Health 4.4
Galveston, TX jobs
**Galveston, Texas, United States** Nursing & Care Management UTMB Health Requisition # 2504804 **Minimum Qualifications:** + Bachelor's degree in nursing and current licensure or valid permit to practice professional nursing in Texas is required. + The equivalent of four years RN experience, including two years progressive management experience is required.
+ Approved specialty certification required, as applicable to assigned program(s)/project(s).
**Job Summary:**
The Program Manager is accountable for the effective strategic planning, and the personnel, operational, and financial management of assigned program(s) and/or project(s), that cross multiple departments and/or services, to ensure optimal quality, cost, and service/outcomes.
**Preferred Qualifications:**
+ Experience leading, coordinating, or supporting accreditation, regulatory compliance, and site visits, including but not limited to the American College of Radiology (ACR), Commission on Cancer (CoC), and National Accreditation Program for Breast Centers (NAPBC).
+ Demonstrated knowledge of quality standards, performance improvement methodologies, and regulatory requirements applicable to oncology and cancer care programs.
+ Experience with data abstraction, reporting, and performance metrics required for accreditation and quality oversight.
**Job Duties:**
+ Assumes a leadership role in effective strategic planning for the program(s)/project(s), incorporating quality, accreditation, and regulatory requirements into program goals and initiatives.
+ Directs the operational management of the program(s)/project(s) to ensure high quality, cost-effective service/outcomes, and a safe and efficient work environment, consistent with accreditation and regulatory standards.
+ Provides leadership and oversight for accreditation readiness, maintenance, and re-accreditation activities, including coordination of site visits, audits, documentation, and corrective action plans as needed.
+ Ensures ongoing compliance with applicable accreditation, regulatory, and quality standards through monitoring, reporting, and continuous improvement efforts.
+ Directs the personnel management of the employees assigned to the program(s)/project(s) consistent with state and federal labor laws, nursing service and hospital philosophy, goals, and policy.
+ Directs the financial management of the program(s)/project(s) to ensure desired fiscal status while supporting quality, compliance, and accreditation-related initiatives.
+ Leads and directs quality improvement activities for the program(s)/project(s), including analysis of outcomes, performance metrics, and patient experience data, and supports nursing research within the program and at the department and service level.
+ Collaborates with interdisciplinary teams, physicians, quality departments, and leadership to ensure alignment with organizational quality and accreditation goals.
+ Identifies appropriate internal controls for the department; provides mechanisms to monitor and enforce compliance with quality, accreditation, and regulatory standards.
+ Promotes and practices patient/family advocacy and facilitates the maintenance of ethical practice.
+ Promotes and practices guest and peer relations.
+ Demonstrates a high level of productivity and dependability.
+ Provides leadership for the program(s)/project(s) and promotes teamwork.
+ Actively promotes the professional development of self and others.
+ Performs related duties as required.
**Salary Range:**
Actual salary commensurate with experience
**Equal Employment Opportunity**
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.
Compensation
$83k-108k yearly est. 60d+ ago
Director of Quality
Freudenberg Medical 4.3
Jeffersonville, IN jobs
Working at Freudenberg: We will wow your world!
Responsibilities:
Lead and assist in the development of direct reports to achieve desired results.
Communicate department goals and objectives, ensuring resources are distributed appropriately.
Maintain regular two way dialogue with direct reports on work and results.
Collaboratively create development plans and coach individuals in achieving them.
Ensure Quality department's participation in the Growtth (Lean) program.
Ensure systems and specific product procedures are in place to release product meeting defined requirements.
Responsible for leading the development and management of an effective and compliant quality system by working closely with various cross-functional members.
Ensure quality performance metrics are implemented, monitored and addressed.
Report to management on the performance of the Quality Management System.
Act as the primary contact for customers regarding quality related issues / activities.
Lead / oversee customer / external audit(s).
Address customer concerns to support strategic approach to the regulations.
Serve as site Management Representative.
Coordinate and conduct management review meetings and ensure closures of management review items.
Ensure continuing suitability, adequacy, and effectiveness of Freudenberg Medical Quality Management System.
Oversee CAPA Review Board (CRB) and ensure appropriate actions are taken to resolve QNs in a timely manner.
Responsible for implementing new or revised global quality systems requirements.
Report and resolve customer recalls and field complaints.
Participate in strategic planning activities to ensure that quality related requirements are included in strategic goals and objectives.
Provide quality solutions to support business activities and other assigned task to support the business.
Promote the awareness of quality throughout the business.
Qualifications:
Bachelor's degree in Science, Engineering, Manufacturing or related field (Master's degree preferred).
Thorough knowledge of medical devices quality systems (ISO13485/FDA).
Knowledge of LEAN and Six Sigma methodologies is desirable.
A minimum of ten (10) years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position.
Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
Experience using SAP ERP software and Proficient in Microsoft Office Suite.
Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg Medical LLC