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Auditor (Non-active Medical Devices)
3 weeks ago
Performs assigned onsite audits at Medical Device Manufacturer’s Premises (Min.50% travel).
- Auditing Quality Management Systems of Medical Devices in accordance with the requirements of the EU Medical Device Regulations 2017/745, and other QMS certification schemes such as EN ISO 13485, MDSAP, ISO 15378, ICMED 13485 and ISO 9001.
- Prepare pre-audit documents, including audit plans, and assist the scheduling team.
- Complete the post-audit documentation on schedule and follow up on its status.
- Assessing technical documentation as part of product conformity assessments of non-active medical devices in accordance with the criteria of the Medical Device Regulation 2017/745.
- Preparing reports included deficiency reports in case of non-conformities according to the requirements of the Medical Device Regulation 2017/745
- Delivering high-quality, reliable, and predictable services within defined timeframes
- Independent supervision of certification projects for our international customers as a project manage.
- Readiness for intensive familiarization with the ISO 13485, ISO 9001, ISO 15378, ICMED 13485, MDR and MDSAP standards and other relevant standards.
- Manages Medical Device Certification projects allotted as Project Handler.
- Support the sales team by providing technical advice to existing and prospective clients.
**Additional Knowledge / Skills**:
- Technical product knowledge in the field of medical technology
- Fluency in written and spoken English.
- Proven qualification as an auditor or quality manger is a plus.
- Sound knowledge of Medical Device Quality Management or Regulation.
- Excellent organizational and professional communication skills
- Ability to work in a team, pronounced customer orientation and good self-organization.
