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Final Reviewer & Certification Decision Maker
@SGS
[Hiring] Final Reviewer & Certification Decision Maker @SGS
Apr 12, 2025 - SGS is hiring a remote Final Reviewer & Certification Decision Maker. 💸 Salary: unspecified. 📍Location: Europe.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
We currently have an exciting opportunity at SGS for a Final Reviewer & Certification decision maker to join our highly successful Global Medical Device team.
In this role you will be reporting to the Final reviewer & Certification decision maker Medical Device Team leader and you will have a Global role.
Main Purpose of Role:
- Review audit packs to verify data and their content for compliance with MDD 93/42 EC or MDR (EU) 2017/745.
- Determine if the certificate shall be issued and if there are any applicable restrictions.
- Verify that audit documentation for QMS on-site and technical documentation assessment is in compliance with medical device regulations and internal procedures.
- Ensure all major non-conformities and any unsolved issues have been addressed and closed out before transferring the audit pack for certification decision.
- Review whether the final review has been carried out by an approved Final Reviewer.
- Confirm whether all actions raised by the Final Reviewer have been satisfactorily addressed and closed out.
- Make the final decision as to whether a certificate should be issued.
- Check audit packs for QMS on-site audit for MDD / MDR / ISO13485, for technical documentation assessment and any changes.
- Take decisions related to audit packs for QMS on-site audit for MDD / MDR / ISO13485, for technical documentation assessment and any changes.
- Be involved in concessions and certificate suspension when relevant.
- Maintain close contact with auditors, product assessors, Certificate Decision makers, and Global Medical Device Certification Manager.
- Contribute to meeting operations objectives and Key Performance Indicators to deliver certificates to customers and maintain regulatory compliance.
Key Accountabilities
- Establish whether the audit report pack demonstrates compliance with specific standards/normative documents and any additional accreditation requirements.
- Verify that the audit has been carried out and associated documentation completed in accordance with relevant procedures.
- Ensure that the auditor/audit team were confirmed as competent.
- Assess whether the auditor/audit team members have applied principles and practices associated with undertaking audits.
- Establish whether Final Technical Review is addressing all Scope of Certification or accreditation issues relevant to specific standards/normative documents.
- Ensure completion of technical review documentation and that no outstanding issues remain unresolved.
- Understand and make judgments on the auditors’ interpretation and reporting of audit findings and decision-making rationale.
- Offer support and help to Certificate Decision Makers.
- Ensure full compliance with the Company’s Code of Integrity & Professional Conduct.
- Maintain and develop personal professional capabilities to ensure knowledge and understanding of sector expectations is up to date.
- Ensure SGS operates in accordance with professional, ethical, legal and accreditation requirements to maintain all approvals.
- Report data on your daily workload and any technical issues.
Qualifications
- Experience in a similar position in a European notified body.
- Significant work experience in the medical device field as Lead Auditor or as Product Assessor in a Notified Body.
- Detailed understanding of global medical device Regulations and good analysis capacity to detect discrepancies or issues.
- Good communication skills.
- Strong team building skills.
- Fluent in English; other languages are a benefit.
Benefits
- Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
- Enjoy a flexible schedule and work model.
- Access SGS University and Campus for continuous learning options.
- Thrive in a multinational environment, collaborating with colleagues from multiple continents.
- Benefit from our comprehensive benefits platform.
Join Us
At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.
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| 📍 | Be aware of the location restriction for this remote position: Europe |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
unspecified
|
Remote
Location
Europe
|
|
Job Type
full-time
|
Posted
Apr 12, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: Europe |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
