Final reviewer & Certification Decision Maker
SGS North America Inc.

Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 93,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.

Job Description

Working as a core member of our global Medical Device team, you will review audit packs and issue certificates in accordance with ISO 13485, MDR (EU) 2017/745 or IVDR (EU) 2017/746 schemes. Additionally, you will ensure that the Final Review has been carried out fully and take certification decision based on all available information for the devices. You will be part of an experienced and supportive team sharing their knowledge and aligning their requirements frequently.

More specifically, you will:

• Conduct final review of all audit pack including on site audit or Technical documentation assessment
• Exchange with auditors or product assessor to improve pack compliance when required
• Ensure timely and accurate completion of technical review documentation;
• Ensure that there are no outstanding issues which remain unresolved;
• Resolve any issues associated with audits such as those relating to reporting audit findings and decision making processes;
• Address any issues relevant to the business/industry environment in which the audit took place.
• Follow internal procedure associate with Certification management process

• Educated to degree level in a relevant subject;
• Proven experience as a Lead Auditor and Product Assessor in the Medical Device area;
• Experience working for a European Notified Body is advantageous;
• Excellent knowledge and understanding of global medical device regulations.
• Fluent in English. Other languages are a benefit.