Quality and CAPA - Project Manager
ConfidentialPune, India6 days ago
Job descriptionBachelor's degree in Engineering, Mechanical or related field. 7+ years' experience in Quality / Regulatory in the medical device industry. Strong knowledge of ISO 13485, 21 CFR 820, EU MDR, and risk management (ISO 14971). Project management skills (PMP, CAPM preferred). Excellent communication, facilitation, and problem-solving skills.
Roles And Responsibilities
- Lead and manage CAPA process from initiation to closure.
- Coordinate root cause investigations and ensure robust corrective actions.
- Track and report CAPA metrics and trends to management.
- Drive quality improvement projects and cross-functional collaboration.
- Ensure timely documentation and regulatory compliance.
- Facilitate audits and provide CAPA-related evidence.
- Support risk management and preventive action initiatives.
Qualifications
Skills Required
Iso 13485, Capm, Pmp, Project Management Skills
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Quality Manager • Pune, India