Medical Device Lead Auditor

Position: Contract Medical Device Lead Auditor
** Your role
**** Medical Device Lead Auditor
** DQS Inc. has an immediate contract opportunity for a Medical Device Lead Auditor. Working closely with your schedulers, 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 or Exemplar Global Lead Auditor or Auditor qualification.
* Ability to develop an audit scope and 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.
** Your profile
*** 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.

EEO is the Law Right to Work Poster (English)    DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled