Quality Systems Manager jobs at Biomat Usa, Inc. - 1075 jobs
RN Quality Program Manager - Oncology
Providence Health and Services 4.2
Renton, 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 managementsystem 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:Renton, WA-98055
$57.9-89.8 hourly 3d ago
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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 managementsystem 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 3d ago
RN Quality Program Manager - Oncology
Providence Health and Services 4.2
Kirkland, 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 managementsystem 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:Kirkland, WA-98083
$57.9-89.8 hourly 4d ago
Supervisor , Continuous Quality Monitoring
Regal Medical Group 3.8
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 1d ago
Organizational Quality Nurse Specialist
Hospice of Michigan 4.7
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.
Are you a current UMass Memorial Health caregiver? Apply now through Workday.
Exemption Status:
Non-Exempt
Hiring Range:
$29.35 - $39.53
Please note that the final offer may vary within this range based on a candidate's experience, skills, qualifications, and internal equity considerations.
Schedule Details:
Monday through Friday, Weekends (Saturday and Sunday)
Scheduled Hours:
7a-7p 7p-7a
Shift:
4 - Mixed Shift, 12 Hours (United States of America)
Hours:
40
Cost Center:
10020 - 2366 Emergency Med Svcs
Union:
NAGE (National Association of Government Employees)
This position may have a signing bonus available a member of the Recruitment Team will confirm eligibility during the interview process.
Everyone Is a Caregiver
At UMass Memorial Health, everyone is a caregiver - regardless of their title or responsibilities. Exceptional patient care, academic excellence and leading-edge research make UMass Memorial the premier health system of Central Massachusetts, and a place where we can help you build the career you deserve. We are more than 20,000 employees, working together as one health system in a relentless pursuit of healing for our patients, community and each other. And everyone, in their own unique way, plays an important part, every day.
Personnel who have competency in airway management, including Medication Assisted Intubation/Rapid Sequence Intubation (MAI/RSI) as well as experience managing episodes of acute clinical decompensation in medically ill patients serve in the North Pavilion (PAV) in capacities consistent with their level or training and scope of practice. All work performed in the hospital will be done under the clinical supervision of the attending physician.
Major Responsibilities:
1. Working in a collaborative fashion as part of the care team with physicians, APPs, PCAs, Unit Secretaries, Respiratory Therapists, and RN staff.
2. When summoned in case of critical decompensation or cardiac arrest, at the direction of the physician or APP, will be responsible for management of the patient's airway according to the Resuscitation and Airway Management Specialist (RAMS) training and scope. The airway procedures will include:
o Use of LMAs and other supraglottic airways.
o BVM ventilation.
o Use of PEEP valve during ventilation.
o Direct laryngoscopy.
o Video laryngoscopy.
o Orotracheal and nasotracheal intubation.
o Use of bougie to assist in intubation.
o Cricothyrotmy in Cannot intubate, cannot ventilate (CICO) situations.
o Placement of orogastric or nasograstric tube.
3. Participate in a program of patient monitoring (known as “Overwatch”) with the following general characteristics:
o Meeting with other clinical staff to identify patients at elevated risk of clinical decompensation and monitoring these patients for any acute changes throughout the course of a shift.
o Responding and interfacing with the interdisciplinary team to help identify management strategies for patients identified in the above activities
o Participate in clinical rounds in coordination with the interdisciplinary care team to review patients' condition and evaluate clinical progress.
4. Establish and maintain peripheral IV access when called upon by the clinical team in cases of patients with difficult IV access.
5. Assisting with transport of critical patients to and from areas of the hospital while monitoring for any acute changes.
6. Performing phlebotomy when needed urgently for “STAT” blood draws or in the case of actuely decompensating patients.
7. Responds according to hospital policies to Visitor/Employee/Outpatient (VEO) emergencies as needed
All responsibilities are essential job functions.
Standard Staffing Level Responsibilities:
1. Complies with established departmental policies, procedures, and objectives.
2. Attends variety of meetings, conferences, seminars as required or directed.
3. Demonstrates use of Quality Improvement in daily operations.
4. Complies with all health and safety regulations and requirements.
5. Respects diverse views and approaches, demonstrates Standards of Respect, and contributes to creating and maintaining an environment of professionalism, tolerance, civility and acceptance toward all employees, patients, and visitors.
6. Maintains, regular, reliable, and predictable attendance.
7. Performs other similar and related duties as required or directed.
II. Position Qualifications:
License/Certification/Education:
Required:
1. Certified in CPR - Basic Rescue by either the American Red Cross or the American Heart Association.
2. Certified in Advanced Cardiac Life Support by the American Heart Association.
Experience/Skills:
Required:
1. At least three years of experience in the care of patients with critical illness within the last 5 years.
2. Experience with Rapid Sequence Intubation with at least 20 intubations performed.
3. Experience with surgical cricothyrotomy.
4. Experience with placement of nasogastric tubes.
5. Experience with placement of peripheral IVs.
6. Experience and training on placement of Intraosseos access device.
7. Demonstrated ability to work well under often stressful situations.
8. Strong organizational and interpersonal skills.
9. Effective oral and written communication skills.
Preferred:
1. Minimum three years of experience in an urban EMS service integrated with a municipal first response system.
2. Pediatric Advanced Life Support (PALS) certification.
Unless certification, licensure or registration is required, an equivalent combination of education and experience which provides proficiency in the areas of responsibility listed in this description may be substituted for the above requirements.
Department-specific competencies and their measurements will be developed and maintained in the individual departments. The competencies will be maintained and attached to the departmental job description. Responsible managers will review competencies with position incumbents.
III. Physical Demands and Environmental Conditions:
Work is considered medium. Position requires work indoors in a patient care environment.
Constantly: Working Indoors.
Frequently: Sitting, Standing, Walking, Pushing, Pulling, Twisting, Reaching, Performing Repetitive Movements, Precise Motor Skills required, Precise Hearing required, Precise Vision required; Lifting, Carrying, Pushing, and Pulling - Less than 10 pounds to 20 pounds.
Often: Balancing, Bending, Kneeling, Grasping, High Level of Stress; Lifting, Carrying, Pushing, and Pulling - 20 pounds to over 100 pounds.
Never: Climbing, Kneeling, Working Outdoors, Working in Temperature Extremes, Working at Heights.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
We're striving to make respect a part of everything we do at UMass Memorial Health - for our patients, our community and each other. Our six Standards of Respect are: Acknowledge, Listen, Communicate, Be Responsive, Be a Team Player and Be Kind. If you share these Standards of Respect, we hope you will join our team and help us make respect our standard for everyone, every day.
As an equal opportunity and affirmative action employer, UMass Memorial Health recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, gender identity and expression, protected veteran status or other status protected by law.
If you are unable to submit an application because of incompatible assistive technology or a disability, please contact us at ***********************************. We will make every effort to respond to your request for disability assistance as soon as possible.
$29.4-39.5 hourly Auto-Apply 3d ago
Manager, Quality and Manufacturing
Hello Heart 3.9
Remote
Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information.
About the Role:
As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production.
Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes.
Responsibilities
Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation
Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones
Create and maintain quality control plans across IQC, IPQC, and OQC processes
Define and implement manufacturing process controls, test requirements, and build validation plan
Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies
Drive corrective and preventive actions and verify long-term effectiveness
Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health
Monitor yields, reduce defects, and drive continuous improvement across production lines
Assess supplier capability and lead onsite production reviews and factory evaluations
Define incoming inspection criteria, sampling plans, and supplier quality alignment
Maintain detailed build documentation, quality dashboards, and audit reports
Qualifications
7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline
Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes
Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma
Proven experience leading root cause analysis and driving corrective actions
Experience working with contract manufacturers and suppliers, preferably in Asia
Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data
Excellent communication skills with the ability to present findings and recommendations
Experience supporting NPI builds and high-volume product ramp is preferred
Familiarity with reliability testing and environmental qualification is preferred
Knowledge of hardware system integration spanning mechanical and electrical components is preferred
Experience with DOE, process optimization, or Lean Manufacturing is preferred
Mandarin language proficiency is a plus
The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits.
Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.
$140k-160k yearly Auto-Apply 13d ago
Clinical Quality Program Manager
Riverstone Health 3.6
Billings, MT jobs
Working title: Clinical Quality Program Manager
Classification title: Medical and Health Services Managers (11-9111)
Department: CHC
Program: CHC Admin
Reports to: Senior Director of Clinical Operations Support
FLSA status: Exempt: Full-Time
Wage Range: $62,35 to $87,896 annually; based on number of years of transferrable experience and internal equity
RiverStone Health:
Serving the Yellowstone County community and south-central Montana for nearly 50 years, RiverStone Health is an essential provider of personal and public health services. Health, Education, Leadership and Protection - HELP is what we do. From medical, dental and behavioral healthcare; home care and hospice; public health services like immunizations, WIC, health promotion and restaurant inspections; and educating the next generation of health professionals, our expertise spans all ages and stages of life.
Underlying principles of access, affordability, compassion and quality in all interactions, RiverStone Health improves life, health and safety for all of the communities we serve.
Program Overview:
The Clinical Quality Program Manager will lead and oversee the development, implementation, and ongoing evaluation of clinical quality initiatives across our Federally Qualified Health Center (FQHC), which is recognized as a Patient-Centered Medical Home (PCMH). This position plays a critical role in advancing the organization's mission to provide high-quality, equitable, and patient-centered care to underserved and diverse populations.
The Clinical Quality Program Manager will be responsible for designing and executing strategies to enhance clinical outcomes and population health to improve patient experience, and ensure compliance with regulatory and accreditation standards, including HRSA, UDS, PCMH, and NCQA guidelines. This role involves close collaboration with medical, nursing, behavioral health, dental, and administrative leadership to foster a culture of continuous quality improvement (CQI), evidence-based practice, and data-driven decision-making.
Job Summary:
Key responsibilities include leading quality improvement initiatives and projects, managing clinical performance metrics, ensuring timely and accurate reporting for internal and external stakeholders, and guiding the organization in achieving excellence in care coordination, chronic disease management, and population health outcomes.
The Clinical Quality Program Manager will champion universal care delivery, leveraging health information technology, informatics and data analytics to reduce disparities and enhance outcomes across the full spectrum of services provided by the health center. This leader will also oversee quality improvement staff and play a key role in provider engagement, education, and performance feedback.
Essential Functions/Major Duties and Responsibilities:
A. Program Management 50%
Oversight of all clinical quality including monitoring, validating, improving and reporting.
Ensure computerized record managementsystems are adequate, communicate IT issues and recommend improvements.
Ensure confidential information is safe guarded.
Plan, implement, and administer projects and other quality improvement initiatives.
Maintain awareness of advances in equipment, IT software, data processing, government regulations and financing options.
Monitor the use of equipment, inventory, facilities and other program resources that affect services provided, including those internal and external to RiverStone Health.
Manage change in integrated health care delivery systems, such as work restructuring, technological innovations, and shifts in the focus of care.
Maintain communication between staff, leadership and other stakeholders by attending meeting, and coordinating interdepartmental functions, maximizing effectiveness and efficiency of interdepartmental operations.
Establish objectives and evaluative operational criteria.
Develop, implement, and ensure adherence to policies and procedures.
Review and analyze facility activities and data to aid planning, risk management and to improve service utilization.
Prepare activity reports to inform management of the status and implementation plans of programs, services, and quality initiatives.
Manage and lead complex programs and services utilizing effective communication, knowledge, resources, and business processes maximizing customer service.
Consult with medical, business, and other local community groups to discuss service problems, respond to community needs, enhance public relations, coordinate activities and plans, and promote RiverStone Health programs.
Develop Quality improvement instructional materials and conduct in-service and community-based educational programs.
Coordinate the operational implementation of EHR and Information System changes as they relate to clinical processes.
B. Program-specific duties 45%
Ensure compliance with all relevant grant requirements including, but not limited to, the Health Resources and Services Administration (HRSA) Operational Site Visit Protocol, FTCA requirements, and NCQA Requirements as related to quality improvement.
Attend meetings, conferences, workshops, and training sessions to become and remain current on developments in areas surrounding quality improvement, project management and community health centers.
Oversees the management and effective implementation of Value Based Care and insurance Payor Contracts.
Lead and facilitate the Project Management process in the health center, to ensure adherence to established priorities and appropriate resourcing for successful project implementation. Including multiple concurrent projects with teams of 3 - 20 members.
Support and encourage innovation from all levels of staff while balancing available resources.
Lead when appropriate and activity participate in RSH projects and committees.
Ensure adherence to a robust Quality Improvement Program and culture, including implementation of a board-approved Quality Improvement Plan and associated procedures, guidelines and education. Actively engage in personal and professional development in Quality Improvement, Project Management, Informatics and other relevant topics, actively identifying and completing self-education as well as recommending and facilitating education for CHC leadership and staff.
Research, implement and manage population health activities that lead to improved patient care, experience, and safety.
Collaborate and share quality improvement practices throughout the state with other health centers.
Ensure that efforts for improvement include a focus on health equity, and that potential disparities in care are addressed.
Champion the adoption of new technologies and practices that support the CHC's commitment to high-quality care.
Non-Essential Functions/Other duties as assigned ≥5%
Perform other duties as assigned in support of RiverStone Health's mission and goals.
Education and Experience:
Minimum Qualifications
Three years of related Health care experience in a quality improvement role, including leading teams.
Project management experience.
Proficiency in data analysis, informatics, and electronic health systems (EHR).
High School Diploma or equivalent
Any combination of experience and training which provide the equivalent scope of knowledge, skills, and abilities necessary to perform the work.
Preferred Qualifications:
Bachelor's degree in a related field
Experience in health care operations and federally qualified health center preferred.
Experience working with underserved population
Medical Terminology
Required Certificates, Licenses, Registrations:
Valid Montana State Driver's License
Lean/Six Sigma Yellow Belt (must achieve within 1 year of hire)
Knowledge, Skills, and Abilities:
Computer literacy, in Microsoft Office Suite.
Ability to maintain a calm and positive demeanor during difficult interactions.
Ability to display non-judgmental and empathetic listening skills.
High degree of detail-oriented skill level.
Knowledge and understanding of protected sensitive patient health information (HIPAA) and confidentiality.
Educate staff and show through example, the significance and meaning of working collaboratively to maintain a positive work environment.
Ability to perform job duties with integrity and innovation to ensure completion and a high level of quality.
Ability to understand and adhere to required administrative policies and procedures.
Excellent communication skills to ensure efficiencies and quality customer service.
Customer Service Excellence:
Doing things right the first time
Making people feel welcome
Showing respect for each customer
Anticipating customer needs and concerns
Keeping customers informed
Helping and going the extra mile
Responding quickly
Protecting privacy and confidentiality
Demonstrating proper telephone etiquette
Taking responsibility for handling complaints
Being professional
Taking ownership of your attitude toward Service Excellence.
Supervision:
No direct supervision
Physical Demands and Working Conditions:
Occasional day travel to satellite clinics required
May be expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, other vehicles, etc. Travel occurs in all weather conditions, including extreme heat and cold.
Work is mainly done on a computer, up to 8 hours a day.
Create and maintain a safe/secure working environment by adhering to safety, security, and health requirements. Integrates injury, illness, and loss prevention into job activities by attending any necessary training and implementing best practices.
Freedom to Act & Decision Making:
Decisions directly affect the quality of services provided to the public.
Considerable leeway is granted for the exercise of independent judgment and initiative.
Communications & Networking:
Presents to large and small groups regularly.
Frequent written and verbal communication with RiverStone staff for the purpose of training and information delivery
Works directly with leadership and department staff to develop quality training sessions
Interaction with professionals across the state for program credentialing and management.
Budget & Resource Management:
Oversight of project and/or associated grant budgets as applicable ($20k - $1million)
$87.9k yearly 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 ManagementSystem (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 ManagementSystem, 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 28d ago
Regional Clinical Quality Program Manager of Perioperative Services
Orlando Health 4.8
Homewood, AL jobs
Baptist Health Alabama Region Baptist Health is seeking a dedicated, experienced Regional Clinical Quality Program Manager to lead peri-operative quality initiatives across its five hospitals in Alabama. This regional role is instrumental in enhancing surgical safety, ensuring compliance with CMS surgical quality measures, and driving continuous improvement in patient outcomes. The Regional Clinical Quality Program Manager serves as a subject matter expert and member of the quality team. Their role includes leading, coordinating, and supporting quality activities and projects at a system or regional level. This position is limited to regional or corporate quality departments. Responsibilities
Region-Wide Quality Oversight: Monitor and evaluate surgical and peri-operative quality performance metrics across all Baptist Health hospitals in Alabama, ensuring alignment with CMS guidelines and internal benchmarks.
Surgical Safety Leadership: Champion best practices in peri-operative safety, including standardized protocols for pre-op, intra-op, and post-op care. Facilitate adoption of evidence-based tools such as surgical safety checklists and time-outs.
CMS Compliance & Reporting: Ensure accurate documentation and timely submission of surgical quality data to meet CMS requirements including IQR and eCQM measures as applicable, infection prevention (SSIs), and adverse event tracking.
Performance Improvement: Lead multidisciplinary reviews and root cause analyses in collaboration with quality and hospital leaders to identify region-wide trends and implement corrective actions. Develop and monitor action plans to achieve measurable improvements.
Education & Engagement: Provide training and support to peri-operative teams on regulatory standards, quality documentation, and continuous improvement strategies in collaboration with regulatory and professional development leaders.
Regional Collaboration: Serve as a strategic liaison among surgical departments, anesthesia, infection prevention, and quality teams across all five hospitals to foster a unified culture of safety and excellence.
Qualifications
Education/Training
Bachelor's degree.
Masters preferred
Licensure/Certification
Registered Nurse
Certification in healthcare quality and safety (e.g., CPHQ, CPPS) within one year of hire.
Experience
Seven (7) years' experience in acute care or other applicable healthcare settings. Five (5) of the seven (7) years MUST be in perioperative services and clinical quality improvement.
Strong knowledge of CMS surgical quality measures and regulatory compliance.
Ability to travel across Baptist Health facilities in Alabama as needed.
$70k-99k yearly est. Auto-Apply 23d ago
Manager, Quality Assurance (GMP External Auditor)
Arrowhead Pharmaceuticals, Inc. 4.6
Pasadena, CA jobs
This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness.
Responsibilities
* Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses
* Assist in generation, tracking, monitoring, and reporting of key quality metrics
* Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams
* Support health authority inspections
* Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings)
* Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations.
* Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs)
* Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures
* Work with Vendor Management Teams on identifying and mitigating any compliance issues
* Oversee contract auditors and others perform audits on behalf of Arrowhead
* Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories
* Other duties consistent with the position as assigned from time to time
Requirements:
* Bachelor's degree in a science discipline is required.
* 5 years of relevant experience in GxP auditing and compliance
* Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines
* Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience
* Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial
* Requires travel to other Arrowhead locations as well as domestic and international travel
$96k-148k yearly est. Auto-Apply 9d 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 12d ago
Manager, Quality Assurance (GMP External Auditor)
Arrowhead Pharmaceuticals 4.6
San Diego, CA jobs
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness.
Responsibilities
Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses
Assist in generation, tracking, monitoring, and reporting of key quality metrics
Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams
Support health authority inspections
Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings)
Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations.
Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs)
Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures
Work with Vendor Management Teams on identifying and mitigating any compliance issues
Oversee contract auditors and others perform audits on behalf of Arrowhead
Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories
Other duties consistent with the position as assigned from time to time
Requirements:
Bachelor's degree in a science discipline is required.
5 years of relevant experience in GxP auditing and compliance
Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines
Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience
Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial
Requires travel to other Arrowhead locations as well as domestic and international travel
California pay range $105,000-$125,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy
$105k-125k yearly Auto-Apply 9d 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 managementsystem 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 13d ago
Manager, Quality Assurance (GMP External Auditor)
Arrowhead Pharmaceuticals 4.6
Pasadena, CA jobs
Job Description
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness.
Responsibilities
Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses
Assist in generation, tracking, monitoring, and reporting of key quality metrics
Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams
Support health authority inspections
Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings)
Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations.
Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs)
Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures
Work with Vendor Management Teams on identifying and mitigating any compliance issues
Oversee contract auditors and others perform audits on behalf of Arrowhead
Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories
Other duties consistent with the position as assigned from time to time
Requirements:
Bachelor's degree in a science discipline is required.
5 years of relevant experience in GxP auditing and compliance
Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines
Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience
Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial
Requires travel to other Arrowhead locations as well as domestic and international travel
California pay range $105,000-$125,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy
$105k-125k yearly 12d ago
Provider Network Quality Strategy Program Manager
Commonwealth Care Alliance 4.8
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
Quality Manager
Freudenberg 4.3
Durham, NC jobs
Working at Freudenberg: We will wow your world!
Responsibilities:
Maintain & Elevate the QMS: Drive continuous improvement and ensure compliance with ISO 9001 and other industry certifications.
Own the Audit Process: Plan and execute internal audits, facilitate third-party and customer audits, and lead corrective actions with precision.
Run the Quality Lab: Oversee daily lab operations, including product testing, inspections, and equipment calibration.
Partner with Leadership: Report on QMS performance and improvement opportunities to senior management, influencing strategic decisions.
Keep Customers at the Heart: Promote customer requirements across the organization to ensure every product meets expectations
Qualifications:
Bachelor's degree in a relevant technical field (e.g., Engineering, Science) or equivalent experience
5+ years experience in a quality leadership or management role
Proven experience implementing and maintaining an ISO 9001 compliant QMS
Experience managing quality control in a manufacturing environment or testing laboratory
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 Performance Materials LP (USA)
$72k-107k yearly est. Auto-Apply 21d ago
Quality Manager
Freudenberg 4.3
Asheville, NC jobs
Working at Freudenberg: We will wow your world!
Responsibilities:
Maintain & Elevate the QMS: Drive continuous improvement and ensure compliance with ISO 9001 and other industry certifications.
Own the Audit Process: Plan and execute internal audits, facilitate third-party and customer audits, and lead corrective actions with precision.
Run the Quality Lab: Oversee daily lab operations, including product testing, inspections, and equipment calibration.
Partner with Leadership: Report on QMS performance and improvement opportunities to senior management, influencing strategic decisions.
Keep Customers at the Heart: Promote customer requirements across the organization to ensure every product meets expectations
Qualifications:
Bachelor's degree in a relevant technical field (e.g., Engineering, Science) or equivalent experience
5+ years experience in a quality leadership or management role
Proven experience implementing and maintaining an ISO 9001 compliant QMS
Experience managing quality control in a manufacturing environment or testing laboratory
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 Performance Materials LP (USA)
$69k-105k yearly est. Auto-Apply 60d+ ago
Supplier Quality Manager
Diasorin 4.5
Cypress, CA jobs
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!
Job Scope
The Supplier Quality Manager is responsible for developing and managing the supplier quality program within an in vitro diagnostics (IVD) manufacturing environment. This role ensures that suppliers of raw materials, components, and services meet applicable regulatory requirements (FDA 21 CFR Part 820, ISO 13485, IVDR) and company quality standards. The Supplier Quality Manager partners with Procurement, Manufacturing, R&D, and Regulatory Affairs to drive supplier qualification, audits, continuous improvement, and compliance.
Duties and Responsibilities
Develop, implement, and maintain the supplier quality management program.
Manage and conduct supplier audits in accordance with FDA, ISO 13485, MDSAP, and IVDR requirements.
Qualify and approve new suppliers, materials, and services for use in IVD manufacturing.
Manage supplier corrective actions (SCARs) and ensure timely resolution of quality issues.
Assign and Manae Supplier Quality Scorecard assessments
Collaborate with Procurement and R&D during supplier selection and qualification.
Review and approve supplier change notifications.
Monitor supplier performance metrics and drive continuous improvement initiatives.
Ensure supplier compliance with product, regulatory, and contractual requirements.
Act as SME during regulatory inspections for supplier management topics.
Manages Regular Supplier Review Board Meetings (global)
Lead risk assessments for suppliers and support overall supply chain risk management.
Other duties as assigned
Knowledge, Experience and Qualifications
Bachelor's degree in Engineering, Life Sciences, or related field required.
Master's degree preferred.
7+ years of experience in Quality Assurance within IVD or medical device manufacturing.
3+ years of experience in supplier quality management or related role.
Proven experience leading audits (internal and external).
Experience with FDA 21 CFR 820, ISO 13485, IVDR, and ISO 14971 risk management.
Training, Skills and Certifications
• Strong knowledge of supplier quality principles, auditing, and risk management.
• Thorough knowledge of FDA regulations and cGMP guidelines. ISO 13485, IVDR.
• Excellent problem-solving and root cause analysis skills.
• Highly organized with proven time-management skills
• Strong communication and negotiation skills with suppliers and internal teams.
• Proficiency with electronic Quality ManagementSystems (eQMS).
• ASQ certifications (CQA, CQE, or equivalent) preferred.
The hiring range for this position is $120,000-$140,000 annual base salary. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.
Travel Requirements
25% Travel may be required
5% International travel may be required
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at ********************* or ************** to request an accommodation.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
$120k-140k yearly 24d ago
Manager, Quality & Value-Based Programs
Tennessee Oncology 4.4
Nashville, TN jobs
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
The Manager, Quality and Value-Based Programs leads cross-functional efforts to drive innovative, efficient, and patient-centered care delivery through the integration of quality improvement, regulatory compliance, and value-based care initiatives. This role collaborates across departments and with executive leadership to develop, implement, and optimize best-practice models that support care transformation, regulatory reporting, and strategic program outcomes.
ESSENTIAL FUNCTIONS:
Works in a collaborative, cross-departmental fashion to facilitate patient-centric care that is innovative, efficient, scalable, patient-safety focused and of high quality.
Works as part of a cross-functional team to establish methods for design, development, and implementation of care transformation activities, care management applications/systems, and regulatory/outcomes reporting.
Builds and leads effective strategies to support the effective delivery and management of key projects.
Responsible for integration and implementation of best practice models that support VBC, Quality, and Regulatory programs.
Collaborates with leaders within the organization to develop strategic plans/approaches for achieving specific program goals.
Develops, implements, and maintains tracking methods to monitor progress related to identified key outcomes continually.
Proactively provides strategic consultation and coordination for the prioritization of major areas of opportunity, incorporating both internal best practices as well as external developments.
Evaluates VBC and Regulatory program changes and impact on program service delivery or model design suggesting modifications as needed to ensure successful patient outcomes as well as meet organizational financial goals/targets.
Works closely with executives and directors to develop and implement standard processes and procedures that assure readiness and achieve initiative(s) success.
Leads the identification and oversight of standard data collection, analysis, reporting and monitoring of essential operational and clinical areas of focus related regulatory issues and recommends methods for process improvement based on performance results. Creates a durable infrastructure model and tools for continuous improvement.
Serves as the organizational expert for regulations, rules, and best practices regarding regulatory requirements.
Works in collaboration with CAO, CMO, Executive/Director Leadership, Compliance Office and Physician Leadership teams to develop specific program goals and infrastructure to align with organizational goals.
Manages programs through creating project plans, management tools, and reporting capabilities.
Develops and initiates a plan to educate departments on relevant regulatory program requirements.
Creates and evaluates policies and procedures as they relate to federal, state, and local regulations as well as regulations regarding organization accreditations.
Assists in organization-wide accreditation application and renewal processes.
Identifies potential regulatory adherence risks and develop strategies to mitigate them.
QPP portal management and annual MIPS reporting.
EDUCATION & EXPERIENCE:
Bachelor's degree required.
Master's degree in relevant field preferred.
Registered Nurse with Oncology experience preferred.
QPP/MIPS reporting experience required.
Certification in Oncology Nursing or Quality Management preferred if Registered nurse or obtain within one year of hire date.
If Non-RN, Quality Management certification preferred, or obtain within one year of hire date.
Minimum of 3 years management experience in healthcare setting or 3 years Quality Management experience with Quality Management Certification.
Strong organizational and communication skills are essential.