About the role
Job Summary:
We are seeking an experienced Senior Post Market Quality Engineer to support post-market quality activities for cardiovascular medical devices. The ideal candidate will have experience in complaint investigations, post-market surveillance, remediation projects, and regulatory compliance within the medical device industry.
Key Responsibilities:
- Investigate product complaints and perform root cause analysis.
- Support Post Market Surveillance (PMS) activities and product performance monitoring.
- Participate in remediation projects and corrective action initiatives.
- Review and document complaint investigations in compliance with FDA and ISO 13485 requirements.
- Collaborate with Quality, Regulatory, R&D, and Manufacturing teams.
- Support CAPA, non-conformance investigations, and risk assessments.
- Prepare and maintain complaint and remediation documentation.
- Ensure compliance with medical device quality and regulatory standards.
Required Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 6+ years of experience in the Medical Device industry.
- Strong experience with Complaint Handling and Post Market Surveillance (PMS).
- Experience supporting Remediation projects.
- Experience with Cardiovascular/Cardiology Medical Devices is required.
- Knowledge of FDA regulations, ISO 13485, CAPA, and risk management.
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