ISO 13485 Lead Auditor
RQM+
Lead Auditor, ISO 13485
RQM+
contract
Posted on:
Location Type: Hybrid
Location: 🇩🇪 Germany
Visit company websiteJob Level
Senior
About the role
- Responsible for project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report.
- Providing the clients with 80% auditor (hats on) and 20% mentor (hats off).
- Identifying and supporting the development of training modules required by the Audit Practice.
- Maintaining their training in new / revised regulations, standards and guidance's as they become available.
- This is a client facing role and the ideal candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits.
- As an auditor there will be challenging situations and difficult conversation with the client. The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right.
Requirements
- A professional and qualified Medical Device ISO 13485 Lead Auditor with extensive auditing experience in the Medical Device industry
- Must have MDSAP auditing experience
- FDA 21 CFR Part 820 experience
- Must be fluent in German and English
- Robust auditing experience
Benefits
- Deeply engrained focus on work life balance
- Ongoing learning and development opportunities
- Industry leading compensation package
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ISO 13485MDSAP auditingFDA 21 CFR Part 820auditing experience
Soft skills
project managementclient facingtactdiplomacyintegritystrength of characterconfidencementoring
Certifications
Medical Device ISO 13485 Lead Auditor
