When you need to be sure
Final Reviewer – Certification Decision Maker
Location
Portugal
Posted
7 days ago
Salary
0
Seniority
Senior
Job Description
Final Reviewer – Certification Decision Maker
SGS
• Review audit packs to verify data and their content for compliance with MDD 93/42 EC or MDR (EU) 2017/745 • Verify that audit documentation for QMS on-site as well as technical documentation assessment complies with medical device regulations • Ensure that major non-conformity and any unsolved issues are addressed before transferring the audit pack for certification decision • Review whether the final review has been carried out by an approved Final Reviewer • Make the final decision as to whether a certificate should be issued • Check audit packs for QMS on-site audit for MDD / MDR / ISO13485 • Contribute to meeting operations objectives and Key Performance Indicators to deliver certificates to customers
Job Requirements
- Experience in a similar position in a European notified body (must have)
- Significant work experience in the medical device field as Lead Auditor or as Product Assessor in a Notified Body (must have)
- Detailed understanding of global medical device Regulations and good analysis capacity to detect discrepancy or issues
- Good communication skills
- Strong team building skills
- Fluent in English
- Other languages are a benefit.
Benefits
- Flexible schedule and hybrid model
- SGS university and Campus for continuous learning options
- Multinational environment where you will work with colleagues from multiple continents
- Benefits platform
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