Telecommute Senior GCP Compliance Auditor

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Posted: Monday, April 09, 2018

Job Category: Healthcare, Quality Assurance

Telecommute Level: 100% Telecommute

Travel Requirements: No Travel

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

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