- LSI Solutions (Victor, NY)
- …root cause techniques in the resolution of CAPAs. + Develop, write, and revise CAPA Quality Management System (QMS) documentation, ensuring that ... meetings. + Maintain, monitor, and present metrics about the CAPA system to management . +...Excel, PowerPoint). + Mechanical aptitude and understanding of mechanical systems . + Experience with 3D modeling or CAD to… more
- System One (Princeton, NJ)
- …degree in science or mathematics + 2-4 years of experience in quality management , with a strong focus on CAPA (Corrective and Preventive Actions) + Proven ... is your chance to play a key role in quality management while contributing to a diverse...analyzing data within the global event management system , particularly for non-conformances and CAPA trends… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Non-compliance (SSN)/issue management (triage/investigation/actions), audit responses, proactive quality management , CAPA oversight, audit/issue trending ... The Regeneron GVP Quality Management Lead (QML) is a...we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system… more
- Terumo Medical Corporation (Elkton, MD)
- Sr Quality Systems Engineer Date: Oct 19, 2024 Req... management and effectiveness of the Quality Management System , primarily the CAPA ... requirements are well understood appropriately incorporated into CAPA documentation and Management Review + Generate Quality System Standard Operating… more
- Terumo Medical Corporation (Elkton, MD)
- …**Job Details:** + Support the management and effectiveness of the Quality Management System , primarily the CAPA system by: + Establishing and ... & Compliance **Job Summary:** The Quality Systems Engineer II drive TMC's Corporate CAPA ...understood appropriately incorporated into CAPA documentation and Management Review + Generate Quality System… more
- Nestle (Savannah, GA)
- …such as 21 CFR Part 111, HACCP, HARPC preferred * Knowledge of Quality Management Systems eg CAPA , Product defense, Pest Control. * Knowledge of auditing ... is responsible for ensuring the compliance of the quality systems , manufacturing processes and associated records...* Facilitates and presents data and information pertaining to quality performance to upper management . * Develops… more
- Stryker (Redmond, WA)
- …Stryker is hiring a ** Quality Systems Specialist, ... you will be responsible for the oversight of the NC/ CAPA process and procedures, and ensure it is compliant,...device regulations. + Ability to gain knowledge in supporting Quality Systems (audits, management review,… more
- Lilly (Durham, NC)
- …One-QMS Steward serves as the site lead overseeing the Quality Management System (QMS) for Central Quality Systems which enables the organization to ... + Implement and maintain the RTP Quality Management System overseeing Deviations, CAPA ,...management , problem solving; mentoring. + Previous experience with Quality management systems including TrackWise… more
- Abbott (Sturgis, MI)
- …**What You'll Work On** The ** CAPA Specialist** progresses investigations through the CAPA system . Works closely with other functional areas with the use of ... Code of Conduct. + Evaluates and progresses the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances,… more
- Integra LifeSciences (Plainsboro, NJ)
- …Project Engineering with capital project implementations. + Utilizes the Computerized Maintenance Management System and manual file systems for ... reports on non-conformance trends, investigation outcomes, and effectiveness of corrective actions for management review during the weekly CAPA and CAPA … more
- Cook Medical (Bloomington, IN)
- …the position, while seeking out opportunities for continuous development and growth* Adhere to the Quality Management System and its processes to meet FDA 21 ... Overview The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA ...of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)* Professional certification (eg ASQ, Six Sigma,… more
- Terumo Medical Corporation (Somerset, NJ)
- …Production Scheduling, Discrete Manufacturing, Shop-Floor Management , Quality Management ( Quality Inspections, Notifications, CAPA ) in Production, ... SAP Quality Management Specialist Date: Nov 7,...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Integra LifeSciences (Boston, MA)
- …Senior Quality Compliance Specialist has responsibility for supporting overall site Quality Management System (QMS) compliance. The Senior Specialist is ... of Quality Compliance and supports the site CAPA program, Quality Management Review...external audits (eg, Notified Bodies and FDA). + Exceptional quality system and regulatory documentation writing and… more
- Katecho (Des Moines, IA)
- …Cause Analysis, Process Trending, Risk Assessment, etc.). + Drives Quality Management System assignments ( CAPA , Deviation, Change Control, GMP tasks) ... in cGMP environment. They will monitor and implement the Quality Systems to ensure compliance with the...Procedures, CAPAs, and any associated compliance records. + Escalates quality issues to management for resolution and… more
- Endo International (Rochester, MI)
- …and adheres to good documentation practices (GDP) + Executes Quality Management System assignments ( CAPA , Deviation, Change Control, Standard Operating ... Knowledge + Knowledge of Enterprise Resource Planning tools (JD Edwards); Quality MS ( Management Systems ), Document MS, Learning MS (Trackwise, Master… more
- Catalent Pharma Solutions (Harmans, MD)
- …for the management and oversight of the core quality systems , including investigation/deviation management , CAPA tracking, change control, risk ... and reporting key quality metrics for Senior Management review, and other quality system...Manages the QA staff supporting Investigation/Deviation/ CAPA Management , Change Control, Risk Management , Quality… more
- Endo International (Rochester, MI)
- …& adheres to good documentation practices (GDP) + Executes Quality Management System assignments ( CAPA , Deviation, Change Control, Standard Operating ... to acquire knowledge/use of Enterprise Resource Planning tools (JD Edwards); Quality MS ( Management Systems ), Document MS, Learning MS (Trackwise, Master… more
- Endo International (Rochester, MI)
- …and adheres to good documentation practices (GDP) + Executes Quality Management System assignments ( CAPA , Deviation, Change Control, Standard Operating ... work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to… more
- 3M (Maplewood, MN)
- …and Suppliers + Experience with championing and/or deploying Quality Management Systems (eg Change Management , CAPA , Complaint Systems , ... and addressing root causes + Leading and providing support for the division of Quality Management Systems + Quality support for New Product Introductions… more
- ThermoFisher Scientific (Swedesboro, NJ)
- …appropriate action to correct unsafe acts and procedures + Strengthen and improve the Quality Management System by coordinating various areas, such as ... Control processes to ensure compliance of product and systems to customer and regulatory requirements. **A Day in...Distribution Quality Assurance, auditing, document management , and CAPA resolution throughout the organization.… more