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!
Apply for QMS Compliance Auditor
Already uploaded your CV? Sign in to apply instantly