Freelance Medical Device Supplier Lead Auditor - Vietnam

Position Overview
We are seeking an experienced freelance lead auditor to conduct on-site supplier audits for medical-device contract manufacturing facilities in Vietnam on behalf of Cisema. Audits shall be performed against ISO 13485:2016, with appropriate alignment to FDA 21 CFR 820 / QMSR requirements. The auditor is required to execute both Cisema-provided audit checklists and Cisema's standard audit protocol, generate independent factual audit findings, and deliver formal audit reports to support supplier-qualification documentation.
Key Responsibilities
Conduct on-site supplier audits for Vietnam-based medical-device contract manufacturers per ISO 13485:2016, taking FDA 21 CFR 820 / QMSR requirements into consideration.
Carry out audit activities following both Cisema-supplied checklists and Cisema's standard audit protocol.
Gather objective audit evidence and produce independent audit findings for supplier-qualification files(non-certification audit).
Prepare full audit reports including non-conformities, observations and recommended corrective actions
Present audit findings and hold closing meetings with site representatives on-site.
Deliver audit reports within agreed turnaround time after on-site audit completion.
Provide auditor credentials and relevant medical-device audit references for Cisema's pre-qualification review.
Required Qualifications & Experience
Valid ISO 13485:2016 Lead Auditor certification (IRCA or equivalent recognized qualification body).
Solid practical experience in supplier or third-party audits for medical-device manufacturing sites, familiar with medical device quality-system controls.
Working knowledge of FDA 21 CFR 820 / QMSR quality-system regulatory requirements.
Prior audit experience at Vietnam-based medical-device contract manufacturers is highly preferred.
Proficient English for audit reporting and internal & external stakeholder communication; Vietnamese-language capability is an advantage.
Willing and available for business travel to manufacturing sites across Vietnam for on-site audit missions.
Available for freelance / part-time project-based engagement and able to adhere to Cisema-agreed project timelines.
Proven track-record of preparing formal audit reports for supplier-qualification purposes.
Expected Deliverables
Auditor credentials and relevant medical-device audit references.
Redacted sample audit report.
On-site audit execution combining Cisema checklist and Cisema standard audit protocol.
Final complete audit report with independent audit findings post each audit engagement.
Project Terms
Engagement type:
Freelance / Part-time, project-based on-site assignments in Vietnam
Remuneration:
Day-rate basis, to be further confirmed during candidate short-listing
Work location:
Multiple medical-device manufacturing sites across Vietnam
Ready to make an impact?
Interested candidates are kindly requested to:
Prepare a cover letter in English
Attach your updated CV together with your job experience and responsibilities
Send your application to:
[protected info]
Please note that only shortlisted candidates will be contacted. Thank you.