MHS Lead Auditor (TUV SUD America, Inc.; Wakefield, MA): Duties and responsibilities: The Medical and Health Services (MHS) Lead Auditor will perform medical device audits in accordance with applicable regulations and standards. Specific duties include: Auditing: Perform regulatory audits of clients per Medical Device Regulations (IVDR, MDR); Medical Device Single Audit Program (MDSAP); international quality system standards (e.g. ISO 13485, ISO 14971); and internal Notified Body and TÜV SÜD America criteria; Perform all related tasks, such as scheduling, planning, reviewing corrective actions, and preparing reports and audit documentation for submission to the certification committee of the Notified Body. File Reviews: Perform evaluations of regulatory submissions including product-specific Technical Documentation assessments (EU Regulations), Design Dossier reviews (EU Regulations). Project Management: Provide project management for NAFTA-based customers; Facilitate the issuance of quotes; Coordinate with other TÜV SÜD America personnel (Account Executives, Project Coordinators, Service Line Managers) to handle a variety of audit projects and other client requests; Identify and coordinate audit teams; Communicate in a courteous and effective manner with internal and external customers in all circumstances, including answering questions, relaying messages, and providing information with regard to international standards and regulatory and technical requirements for compliance purposes. Based at HQ: 401 Edgewater Place, Suite 500, Wakefield, MA 01880; telecommuting is allowed pursuant to company policy. Extensive domestic travel to client sites required; some international travel may be required.
Minimum requirements: Master's degree or foreign equivalent in Bioengineering, Regulatory Science, Project Management, or a related field PLUS 3 years of experience in an industrial medical device environment in Product Design, Product Development, or Manufacturing of IVD, Non-Active Medical Products, or Active Medical Products; including at least 1 year of experience with quality management-related activities, such as design control, process/product/method validation, design transfer, risk management, manufacturing controls, or QC testing.
Apply online at https://www.tuvsud.com/en-us/careers or send resume to: Dennis Moore, Manager, Talent Acquisition, TUV SUD America Inc., 401 Edgewater Place, Ste 500, Wakefield, MA 01880. Ref: 00061323. An EOE.