Certification Decision Marker
SGS North America Inc.

Job Info

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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 MDD 93/42 EC, ISO 13485, or MDR (EU) 2017/745 standards. Additionally, you will ensure that the Final Review has been carried out by an approved Final Reviewer and that all documentation has been completed satisfactorily and any issues resolved.

More specifically, you will:

• 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.

Qualifications

• Educated to degree level in a relevant subject;
• Proven experience as a Lead Auditor or 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.

This job has expired.