Telecommuting Compliance Senior Auditor

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Posted: Thursday, March 08, 2018

Job Category: Quality Assurance

Telecommute Level: 100% Telecommute

Travel Requirements: No Travel

Weekly Hours: Flexible, Full Time

Employment Status: Permanent

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Additional Information: Benefits Available

Job Summary

A health technology company is seeking a Telecommuting Compliance Senior 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

Must meet the following requirements for consideration:

  • 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)
  • Ability to communicate effectively both orally and in writing
  • Strong organizational and interpersonal skills