- Aldevron (Miami, FL)
- …a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation. You will assist in representing the Analytical Method ... to Root Cause identification and Corrective Actions and Preventative Actions ( CAPA ).Develop and execute data collection plans, interpret data, draft protocols and… more
- IQVIA (Durham, NC)
- By joining us as a **QA CAPA Manager within Clinical Trials and GCP** you will support global investigations and CAPA processes at IQVIA. This will include ... and Customer Audit/ Regulatory Inspection Responses, Corrective and Preventative Action ( CAPA ) and Effectiveness Check (EC) plan review, approval, and closure.… more
- Catalent Pharma Solutions (Harmans, MD)
- …meetings, and communication of CAPA -related metrics to key stakeholders. The CAPA Manager will collaborate with cross-functional teams to ensure quality ... **Senior Manager , CAPA ** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop,… more
- Hologic (Marlborough, MA)
- Global CAPA & Compliance Manager Marlborough, MA, United States Are you an experienced Quality leader with a passion for compliance and driving impactful change? ... Hologic is seeking a Global CAPA and Compliance Manager to oversee and ensure a robust and compliant CAPA and Nonconforming process. This role is also… more
- Cook Medical (Pittsburgh, PA)
- …by helping others, and driven by integrity, we invite you to apply. The Manager , Investigations, CAPA and Complaints at Cook MyoSite, Inc. is responsible for ... overseeing all activities performed by the Investigations Writing team. The manager works closely with QA Management to ensure Investigations, CAPAs, and Complaints… more
- Catalent Pharma Solutions (Harmans, MD)
- …timely manner. The ** CAPA Specialist III** will work closely with the CAPA Manager and cross-functional teams to drive effective corrective and preventive ... properly documented and processed in a timely manner. + Support the CAPA Manager in coordinating and facilitating CAPA meetings, ensuring follow-up actions… more
- Danaher Corporation (Brea, CA)
- …activities. In addition, the CAPA GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This position is part of the ... the development, governance and integration of the Corrective and Preventive Action ( CAPA ) process into our global Quality Management System (QMS) in all aspects… more
- Fresenius Medical Center (Waltham, MA)
- **PURPOSE AND SCOPE:** The Senior Engineer, CAPA is responsible for coaching CAPA Engineers to ensure CAPAs (corrective and preventive action) and ... **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality Systems personnel… more
- Fresenius Medical Center (Waltham, MA)
- **PURPOSE AND SCOPE:** The CAPA Quality Engineers are assigned Corrective Action and Preventive Action ( CAPA ) investigations as well as Non-Conformance (NC) ... NCs. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality Systems personnel… more
- Teleflex (Chelmsford, MA)
- …trends and report findings to management. * Assist in the Quality Systems Manager with CAPA 's as needed. * Assist in the development, implementation, ... and maintenance of the quality management system (QMS) in compliance with regulatory requirements (eg, FDA, ISO 13485). * Coordinate and manage the training nonconformance curriculum for employees, ensuring compliance with quality system requirements. *… more
- Terumo Medical Corporation (Campbell, CA)
- Sr. Manager , Quality Kalila Date: May 19, 2025 Req ID: 4433 Location: Campbell, CA, US Company: Kalila Medical Inc. Department: Kalila QMRA **Job Summary** Senior ... Manager , Quality has primary responsibility for establishing and maintaining...including Management Oversight, Supplier Controls, Equipment Controls, Nonconformance Management, CAPA , Complaint Handling and Adverse Event Reporting, Corrections and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- The Sr. Manager Quality Management System is responsible for monitoring the effectiveness of the GxP Quality Management Systems regarding CAPA , Deviations, ... OPDC/OAPI. S/he is the Global process owner for the CAPA and Deviation. S/he will support the development and...Provide guidance and perform a risk assessment for global CAPA and Deviation. Provides guidance to quality record owners… more
- ThermoFisher Scientific (St. Louis, MO)
- …and ensure food safety. We support your career goals. **Job Title: Sr Manager , Manufacturing Compliance** **Reports to: Vice President / General Manager ** ... SOPs, batch records, and other controlled documents. Coordinate deviation management, CAPA execution, and change control processes for Operations. + **Promote… more
- Olympus Corporation of the Americas (San Jose, CA)
- …of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the ... of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the… more
- Abbott (Pleasanton, CA)
- …their health and get on with their lives. As a Senior Quality Compliance Manager , the individual will play a crucial role within Abbott's Heart Failure organization ... compliance gaps. + Responsible for oversight and administration of division's CAPA system and driving effective resolutions to identified issues. + Responsible… more
- Astrix Technology (Fort Worth, TX)
- **Quality Assurance Manager - Medical Device** Quality Assurance Fort Worth, TX, US Pay Rate Low: 85000 | Pay Rate High: 90000 + Added - 04/06/2025 Apply for Job ... grow in the life sciences industry!_ _Our Quality Assurance Manager position is a great opportunity to work with...industry experience + 4+ Years of Quality Assurance and CAPA management + Leadership experience **Pay:** $85k-$90k **Schedule:** 1… more
- Pentax Medical (Montvale, NJ)
- …imaging devices and solutions to the global medical community. Position Opening: Manager , Production/Manufacturing Why JOIN Us? We are an established medical device ... and generous Paid Time Off and Holiday policy. Want More INFO? The Manager of Production/Manufacturing is responsible for overseeing the activities for the ENT… more
- Tecomet (Manchester, NH)
- **POSITION SUMMARY:** The Quality Assurance & Regulatory Affairs Manager oversees the quality management system (QMS) and ensures compliance with 21 CFR | Part 820, ... completeness, and compliance; + Develop and implement Corrective and Preventive Actions ( CAPA ) to address nonconformances, trends, and regulatory issues by managing … more
- ThermoFisher Scientific (Florence, KY)
- …Risk Assessments & Data Integrity. **Discover Impactful Work:** The Site Quality Manager is responsible for ensuring that products received & distributed are ... such as Distribution Quality Assurance, auditing, document management & revision, CAPA resolution, Change Control, Discrepant Material and Risk Management in order… more
- Zimmer Biomet (Warsaw, IN)
- …regulated industry experience; and + total engineering project experience including leading CAPA process use DMAIC methodology. Must have 2 years of experience with ... following: + Apply statistical analysis for quality control/assurance and CAPA verification of effectiveness plan; + review and approve... verification of effectiveness plan; + review and approve CAPA metrics and quality system records in a manner… more
