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 #J-18808-Ljbffr