Manager CAPA
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
- Lead strategic planning for CAPA goals, metrics, and continuous improvement initiatives.
- Anticipate regulatory changes and proactively manage risk.
- Establishment and maintenance of Quality System policies, systems and procedures as needed to ensure compliance of the CAPA program.
- Directly supervises a team of CAPA Investigators and CAPA analysts and leads an extended team of qualified investigators with members from multiple functional areas across the site/division in the performance of non-conformance investigations and corrective actions.
- Oversee CAPA investigations and ensure timely, thorough, and compliant documentation.
- Drive cross-functional collaboration for CAPA program across Operations, R&D, Marketing, Supply Chain, Quality and Regulatory.
- Establishes Training material and approaches for members of the CAPA program and ensures training strategies maximize performance and compliance with worldwide regulatory requirements & expectations.
- Leads the CAPA Review Board (CRB) process; executes Quality signatory authority for the review and disposition of non-conforming product in accordance with regulatory requirements.
- Execute the Executive Management Review Program and present key quality metrics to senior leadership.
- Division Liaison to the Corporate Quality organization in the maintenance of the global system for Exception reporting and CAPA and for the Quality Systems Data Warehouse (QSDW).
- Serves as the primary CAPA system contact during regulatory inspections and Corporate AQR audits.
- Foster a culture of growth and opportunity through coaching and development.
- Develop, maintain and manage the department budget and related goals for the CAPA program.
- B.S. or an equivalent combination of education and work experience will be accepted
- 5 years experience in a regulated environment to be able to understand complex processes.
- 5 years related experience in a quality discipline, CAPA preferred.
- 5 years management experience.
- Good working knowledge of regulations and standards affecting IVDs and Medical Devices.
- Strong Problem-Solving Skills.
- Experienced in effective verbal and written communications.
- Excellent interpersonal skills.
- Ability to communicate effectively across all levels of the organization.
- Computer literate with excellent knowledge of databases, spreadsheet and word processing.
- Project Management experience is preferred in order to effectively manage and coordinate various improvement projects across functional areas and across sites.
- Strategic and forward-thinking with a global perspective.
- Highly collaborative and influential across all levels.
- Calm under pressure; strong audit and inspection presence.
- Committed to continuous improvement and employee development
- Ability to travel approximately 10%, including internationally.
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