Quality and CAPA
4 weeks ago
Job Description
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
- Bachelor'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.
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