Join one of the industry-leading Notified Bodies dedicated to upholding the highest standards of quality and safety in the medical device industry. Our organization plays a critical role in ensuring compliance with regulatory requirements and international standards to safeguard patients and healthcare professionals worldwide.
Position Overview: We are seeking an experienced and driven Medical Device Audit Manager to lead our team of auditors and oversee audit operations for medical device manufacturers. The successful candidate will leverage their expertise in quality management systems and regulatory compliance to drive excellence in audit processes and ensure the integrity and effectiveness of our auditing activities.
Key Responsibilities:
- Lead and manage a team of medical device auditors, providing guidance, mentorship, and support to ensure the delivery of high-quality audit services in accordance with regulatory requirements and industry standards.
- Develop and implement audit plans, schedules, and protocols to effectively assess the compliance of medical device manufacturers with relevant regulations, including ISO 13485, MDSAP, EU Medical Device Regulation (MDR), and FDA requirements.
- Coordinate and conduct audits of medical device manufacturers' quality management systems, manufacturing facilities, and product documentation to verify conformity with applicable regulatory requirements and standards.
- Review audit reports and findings prepared by auditors, ensuring accuracy, completeness, and consistency in documentation and compliance assessment.
Qualifications:
- Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
- Minimum of 4 years of experience in medical device auditing, quality management, or regulatory affairs, with at least 3 years in a supervisory or managerial role.
- In-depth knowledge of medical device regulations and standards, including ISO 13485, MDSAP, MDR, and FDA requirements.
- Professional certifications such as Lead Auditor Certification (e.g., ISO 13485 Lead Auditor), Certified Quality Auditor (CQA), or Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferred.
