Auditor / Lead Auditor

Job summary
DNV Supply Chain and Product Assurance is seeking experienced Medical Device Auditors and Lead Auditors to conduct audits of medical device manufacturers.Candidates must have a relevant educational degree and a minimum of 4 years of work experience in the medical device or healthcare products industry.The successful candidate(s) will verify conformity with ISO 13485, MDSAP, and the Medical Device Regulation (EU 2017/745) in order to deliver certification services.
Job seniority: mid-to-senior level
Responsibilities
• Audit manufacturers to ensure compliance with regulatory requirements, ISO 13485, MDSAP, and the Medical Device Regulation (EU 2017/745).• Apply knowledge of regulatory requirements to manufacturers' processes, management systems, and products.• Document and report audit activities and results, provide timely reviews of customer corrective actions.• Analyze complex regulatory requirements and determine the proper course of action.• Work independently or within a team environment and maintain appropriate auditor credentials.
Requirements
• Must have a university or technical college degree in a relevant field such as Biomedical Engineering, Mechanical Engineering, Chemistry, or Pharmacy.• Minimum 4 years of work experience in the medical device or healthcare products industry, with at least 2 years in manufacturing, auditing, or research.• Knowledge of medical device management systems, regulatory requirements, and auditing techniques.• Experience with medical device standards and risk management.• Strong interpersonal, verbal, and written communication skills.• Ability to travel domestically and/or internationally, estimated up to 60%.