Enfermeiro Auditor Supervisor overseeing audit processes and clinical conditions in healthcare management. Collaborating with external teams and clients for operational improvements and quality assurance.
About the role
- Auditor role in a MedTech CRO managing internal audits for various clients. Delivering regulatory and quality expertise in the medical device industry.
Responsibilities
- 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 English
- Robust auditing experience
Benefits
- Industry leading compensation package
- Ongoing learning and development
- Work life balance
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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