Job Summary
A technology company has an open position for a Telecommute Senior GCP Compliance Auditor.
Individual must be able to fulfill the following responsibilities:
- Planning, coordinating, and executing QMS audits as Lead Auditor or Auditor,
- Reviewing responses to audit findings for completeness and effectiveness
- Providing audit coaching/readiness training, and support for external audits
Position Requirements Include:
- BS/BA plus a minimum of 5 years experience in a medical device or regulated industry
- Certified Lead Auditor; or ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA); or Certification with a recognized Accreditation body (i.e. RAB-QSA / IRCA) In-depth knowledge of FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282)
- In-depth knowledge or experience of medical device regulatory requirements
- Working knowledge of appropriate global medical device regulations, standards, and requirements
