QMS Compliance Auditor

Recruiter
Location
Amsterdam, Netherlands
Salary
competitive
Posted
14 Nov 2016
Closes
14 Dec 2016
Ref
PR-32496960
Contact
Sjoerd Spoelstra
Sector
Engineering
Category
Quality
Contract Type
Contract
Hours
Full Time

Period: 12/12/2016 - 08/12/2017

Location: Amsterdam

Your responsibilities:

  • 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!

Sjoerd Spoelstra

s.spoelstra(at)progressiverecruitment.com

010-2069888