Auditor / Lead Auditor

Job summary
DNV Supply Chain and Product Assurance is looking for Medical Device Auditors and Lead Auditors throughout North America. The successful candidate(s) will be responsible for conducting audits of medical device manufacturers.This position can be remote from anywhere in the Continental U.S.A.
Job seniority: mid-to-senior level
Responsibilities
• Conduct audits of medical device manufacturers to verify conformity with ISO 13485, MDSAP, and the Medical Device Regulation (EU 2017/745).• Utilize knowledge of regulatory requirements and apply them to manufacturers' processes, management systems, and products.• Document and report audit activities and results, analyzing complex regulatory requirements and making sound determinations.• Provide reviews of customer corrective actions and work with minimal supervision.• Maintain appropriate auditor credentials and complete all chargeable work within required budget and timeframes.
Requirements
• Must have completed a university or technical college degree in a relevant field (Biomedical Engineering, Mechanical Engineering, Chemistry, etc.).• Must have 4 years of professional experience in the medical device industry, with at least 2 years in manufacturing, auditing, or research and quality management.• Must possess knowledge and understanding of a wide range of medical device or healthcare technologies and/or products.• Must be able to audit medical device manufacturers Quality Management System(s) for conformity with applicable regulations and standards.• Auditor training and experience according to ISO 13485, MDR (EU 2017/745), and MDSAP is a plus.• Must have excellent interpersonal, verbal, written, and presentation skills.• Current valid driver's license is required. Domestic and/or international travel is estimated to be up to 60%.
Benefits
• Generous Paid Time Off• Multiple Medical, Dental, and Vision Benefit Plans• Spending Accounts - FSA, Dependent Care, Commuter Benefits, Company-Seeded HSA• 401(K) with company match• Company provided life insurance, short-term, and long-term disability benefits• Education reimbursement program• Employer-Paid, therapist-led, virtual care services through Talkspace• Flexible work schedule with hybrid/remote opportunities