- Philips (Cambridge, MA)
- The Senior Quality Manager - CAPA will play a critical role within Philips' Global Patient Safety & Quality organization by leading and managing the Corrective and ... Preventive Action ( CAPA ) Program/Team for our global operations. **Your role:** +...Global Quality Oversight, including strategic leadership and governance for CAPA activities across multiple regions, ensuring consistency and compliance… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose The Manager , CAPA & Post-Market Surveillance (" Manager ") is part of ... Director, Medical Device & Combination Products Shared Services (or equivalent). The Manager leads a team that processes, analyzes, and evaluates post-market data in… 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
- Abbott (Columbus, OH)
- …Action program for all MCS sites (five different locations). + Oversees the CAPA process from initiation to effectiveness review and ensure the CAPA ... + Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge. + Assess resource needs to assure...& Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts… more
- Insight Global (Cambridge, MA)
- …employees, and managers on all levels - Medical device industry experience Project Manager background, especially over CAPA activities null We are a company ... Description Insight Global is seeking a SME in Corrective and Preventative Actions ( CAPA ) to analyze and advise involved teams throughout the various end-to-end … 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
- Abbott (Alameda, CA)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. **Staff CAPA Engineer** **Working at Abbott** At Abbott, you can do work that matters, ... Opportunity** You will be responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at… more
- Post Holdings Inc. (Lawrence, KS)
- …& Facility inspection programs for the site, and log and track all findings in the CAPA system. Support QFS Manager with FDA and Kansas Dept. of Ag documentation ... the work" culture. Partner with Quality & Food Safety Manager to develop and deliver QFS goals and initiatives....and inspections. CAPA Activities: Enter audit findings in CAPA … more
- Danaher Corporation (Fargo, ND)
- …of the Quality Control Clinical team, report to the QC Release Testing Manager , and be responsible for ownership of various technical writing and continuous ... improvement projects including deviation investigations, CAPAs, and change controls. In this role, you will have the opportunity to: + Lead and author deviation investigations including root cause analysis, trend investigation, and impact assessment + Manage… more
- System One (Quakertown, PA)
- …career? We are looking for a passionate and results-driven Quality Management Systems Manager to lead our CAPA processes, manage audits, and collaborate with ... Title: Quality Management System Manager Location: Quakertown (On-site) Schedule: M-F 8 am-5...we want to hear from you! Responsibilities: + Lead CAPA processes, including root cause analysis, corrective/preventive actions, and… more
- AssistRx (Des Moines, IA)
- …HIPAA, and other applicable regulations. + Assists in Incident Management and CAPA process. + Assists Compliance Manager in conducting enterprise-wide Risk ... and privacy of patient and customer data. + Assists the Compliance Manager with performing internal reviews, research and/or audits to verify compliance with… more
- Philips (Cambridge, MA)
- …design history file requirements, end-of-life process, Quality Systems (eg, CFR Part 820) and CAPA management. + Act as the project manager and partner with the ... **Sr. Program Manager - Product & Process Development and Remediation, Consent...product compliance with a focus on design & development, CAPA 's, and the associated process & production controls in… more
- J&J Family of Companies (Santa Clara, CA)
- …to address audit findings. Supports investigations/actions associated with non-conformances and CAPA , as directed by Quality manager . (10%) **Requirements** + ... the organizational goals, quality system improvement initiatives as directed by Quality manager and performs other related duties as assigned by management (10%) +… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** **The Senior Manager ,** **GPV Compliance & Business Management will support the** **leads of Global PV** **Audit & Inspection readiness** **(AIR)** ... **activities** **and** **Global PV** **Corrective Action** **Preventative Action** **(** ** CAPA ** **)** **and Deviation** **for the processes managing and… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …and success for Site Key Process Indicators (KPI), to guide and lead CAPA coordinators, and to ensure CAPA activities are appropriately and consistently ... deficiencies are corrected per policy. + Leads and guides CAPA coordinators in the Americas. Hosts Regional CAPA...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**… more
- Terumo Medical Corporation (Campbell, CA)
- Sr. Manager , Quality Kalila Date: Apr 20, 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
- Integra LifeSciences (Columbia, MD)
- …test method validations and monitoring procedures. + Change control, non-conformance and CAPA support. + Support the department manager with providing direction ... to the team, coordinating work flow, and providing guidance in the resolution of problems or areas of concern + Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. **DESIRED MINIMUM QUALIFICATIONS** The requirements… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …address changes to minimize impact on commercial and investigational product availability ** CAPA Management** + Ensure oversight of CAPA Management activities + ... promptly with internal and external stakeholders + Monitor and enforce CAPA completion deadlines per internal procedures **Product Data Management** + Collect… more
- Abbott (Columbus, OH)
- …Quality Assurance.** This individual will serve as the primary account manager for all things quality for multiple suppliers that manufacture nutritional ... within this role include: (1) event management and responsibilities for the Abbott CAPA system, (2) project management as it relates to new product launches, trials,… more