QMS Compliance Auditor
Period: 12/12/2016 - 08/12/2017
- You will be responsible for contact managing the relationship between the organisation and the entities that assess preordained standards for the market.
- You will be a liaison between multiple parties, and manage relations between these entities and internal stakeholders.
- You will plan, coordinate and execute QMS audits as the Lead Auditor.
- You will compile and report metric for the audit program.
- You will review the responses to the audit findings for effectiveness and completeness.
- You will manage the group of part-time volunteer auditors in a constructive and clear way.
What we are looking for:
- Bachelor's (or higher) degree.
- Minimum 5 years of experience in a regulated industry (i.e. medical devices).
- Worked as a Certified Lead Auditor, Certified Quality Auditor, and/or Certified Bio-medical Auditor.
- Excellent knowledge of FDA's 21 CFR 820, ISO 13485, ISO 14971, EU Medical Device Directive (93/42/EEC), JPAL, ANVISA, Canadian Medical Devices Regulation (SOR/98-282).
- Government or regulatory-body Quality System auditing experience preferred (i.e. FDA)
- Able to drive operation excellence when working with your audit teams and partners.
- Able to evaluate risks and able to take ownership.
- Good analytical skills and process improvement capabilities.
- Excellent communication skills in English.
- Willingness to travel worldwide (average of 25%).
If you think you are up to the task, do not hesitate to contact me and sent me your most recent CV!