Medical Device Lead Auditor


Medical Device Lead Auditor

  • Company: DQS Inc.
  • Location: Anu US Location, Illinois
  • Part Time/Full Time: Fulltime- Contract


** Midwest **

Medical Device Lead Auditor (Contract)

DQS Inc. has an immediate contract opportunity for a Medical Device Lead Auditor. Preferred location is the Midwest or California. Working closely with your scheduler you will visit client locations and perform the audits as specified. Position is home based with extensive travel.

Job Responsibility:
· Knowledge of principles and methods for management systems audits.
· Experience with internal, 2nd or 3rd party ISO-9001, ISO 13485, and/ or GMP auditing.
Preference given to RAB-QSA Lead Auditor or Auditor qualification.
· Ability to develop an audit scope, audit plan and manage audit team activities.
· Ability to present the audit team conclusions to the customer and review customer resolution of any nonconformities.
· Must be able to assess customer needs and meet UL DQS service and customer satisfaction standards.
· Work independently and project a professional image appropriate to the work environment.
· Extensive travel.

· Bachelor’s degree in a physical or life science or electrical, mechanical or biotechnology engineering required
· Minimum of four years experience in quality systems management.
· Minimum of four years experience in medical device development, manufacture and/or testing, with demonstrated knowledge of US, Canada and EU medical device regulatory requirements, experience with device submittals and knowledge of risk management principles such as ISO 14971.
· Passed or ability to pass an accredited 40-hour ISO 9001 or ISO 13485 lead auditor course.
· Experience in implementation of ISO 13485, MDD and/ or CMDCAS desired.

DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled

How to Apply:

< Back to Careers