- IQVIA (Raleigh, NC)
- …Main responsibilities will include, but are not limited to: + Act as process and system SME for the nonconformance and CAPA process and business/ system ... Escalate any issues, as needed, to the BRQC Janssen CAPA Review BoardRaise any process or system ...+ Experience in Quality Control and Compliance, Quality Assurance, CAPA process and/or Root Cause… more
- Medtronic (Los Angeles, CA)
- … Quality Engineer is responsible for implementing, maintaining and improving the Quality Management System at the Diabetes sites. Specifically review ... must be comfortable coaching all employees on the SR Quality Management System and working...Update and/or manage Quality Metrics. Assist with Management Review and CAPA Board meeting preparations.… 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: Sep 20, 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 (Somerset, NJ)
- …**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
- ThermoFisher Scientific (Pittsburgh, PA)
- …the process owner and champion for key elements of the CCG Quality Management System , including CAPA , Compliant Handling, and Internal Audit. + ... Manager** is responsible for the development, implementation, coordination, and measurement of Quality Management System processes within the Customer… more
- Teleflex (Chelmsford, MA)
- …lead, manage, and drive improvement in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection ... Summary** The Quality Engineer III will be responsible for cross-functional quality assurance, quality management /compliance, quality control, and… more
- Amicus Therapeutics (Marlow, OK)
- …readiness, KPIs/metrics, and QMS system validations. The Senior Director, Global Quality Management Systems will work collaboratively with all parts ... systems for day-to-day GxP operations related to Quality Events, Investigations, CAPA , Change Management...quality throughout the company. Roles and Responsibilities: + Quality Management System (QMS) +… more
- Abbott (Columbus, OH)
- …OF ROLE The CAPA Process Analyst I: * Progresses investigations through the CAPA system in support of non- CAPA organizations. * Works closely with ... RESPONSIBILITIES * Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised...ISO13485 is preferred. + Able to apply strategic and quality logic and project management skills to… more
- Abbott (Altavista, VA)
- …families around the world. The CAPA Specialist progresses investigations through the CAPA system in support of non- CAPA organizations. This position ... On** + Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised...experience performing investigations. + Able to apply strategic and quality logic and project management skills to… 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
- Stryker (Mahwah, NJ)
- …and understanding of US and International Medical Device Regulations. + Experience in supporting Quality Systems (eg Audits, Management review, Quality ... it is compliant, effective and efficient in dealing with quality issues. The Senior CAPA Specialist will...Error Reduction, 4-D etc. + Highly proficient on NC/ CAPA procedures, and super user of eCAPA system… more
- Abbott (Columbus, OH)
- …YOU'LL WORK ON** + The ** CAPA Coordinator QA** 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
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …**Job Description** **About the role:** The Quality Associate II - Deviation and CAPA is in the Quality Systems organization at the Takeda Round ... serve as the administrator for the electronic deviation and CAPA system and for the deviation and...responsibilities will be to support other quality system processes including change control management , document… more
- GE HealthCare (Florence, SC)
- …+ Creates a Quality culture by driving compliance activities, supporting the total quality management system , and site trending to achieve Quality ... CAPA as applicable. + Support achievement of site Quality objectives and QMS systems + Impacts...in the medical device field. + Demonstrated knowledge of Quality Management System tools &… more
- AbbVie (North Chicago, IL)
- …primary goals, objectives or functions or outputs of this position. Oversees the plant CAPA Quality System by performing root cause investigations for ... the implementation and maintenance of the Quality System + Ensures all Quality CAPA...problem solve and utilize analytical skills + Knowledge of Quality /Compliance management , Regulations and Standards Additional Information… more
- Abbott (Tipp City, OH)
- …+ Experience in leading CAPA investigations + Experience with ABTRAQ or other quality management system + Project management experience + Extensive ... On** + Implement and maintain the effectiveness of the quality system + Maintain the effectiveness of...regulated manufacturing environment + Able to apply strategic and quality logic andproject management skillsto investigation activities… 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: Sep 10,...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Actalent (Maple Grove, MN)
- … Management system - 3+ years + Quality Management System - 3+ years + CAPA /GMP experience Soft Skills + Attention to detail + Problem-solving ... quality and compliance issues, author/review procedures within the Blood Product Quality Management System , and provide metrics and data-driven solutions… more