Senior Auditor

Job Title : Qualified Medical Device Auditor

Location : Germany

About Us : I am supporting a leading Notified Body in the medical device industry, renowned for our commitment to quality and safety in the healthcare sector.

They provide certification, testing, and auditing services to ensure that medical devices meet regulatory standards and contribute to patient safety.

Job Overview : They are seeking a highly qualified and experienced Medical Device Auditor to join their team in Germany.

The ideal candidate will have a strong background in the medical device industry, exceptional auditing skills, and in-depth knowledge of regulatory standards.

This role involves conducting thorough audits of medical device manufacturers to ensure compliance with relevant regulations and standards.

Key Responsibilities :

• Conduct comprehensive audits of medical device manufacturers to assess compliance with European and international regulations (e.g., MDR, ISO 13485).
• Evaluate technical documentation, quality management systems, and manufacturing processes.
• Prepare detailed audit reports, outlining findings, non-conformities, and recommendations for corrective actions.
• Collaborate with cross-functional teams to ensure consistent and thorough audit processes.
• Stay updated on changes in medical device regulations and standards to provide accurate and current guidance to clients.
• Provide training and mentorship to junior auditors and other team members as needed.
• Participate in internal and external meetings, representing the notified body with professionalism and expertise.
• Support clients in understanding and implementing regulatory requirements.

Qualifications :

• Bachelor's degree in engineering, biomedical sciences, or a related field; advanced degree preferred.
• Certified Lead Auditor qualification in ISO 13485 and / or relevant medical device regulations.
• Minimum of 5 years of experience in the medical device industry, with at least 3 years in a regulatory or quality assurance role.
• In-depth knowledge of EU Medical Device Regulation (MDR), ISO 13485, and other relevant standards.
• Strong analytical skills and attention to detail.
• Excellent communication and interpersonal skills, with the ability to interact effectively with clients and regulatory authorities.
• Proficiency in German and English, both written and spoken.
• Ability to travel within Germany and internationally as required.
Vor 13 Tagen