[Hiring] Medical Device Lead Auditor @DQS

Role Description

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.

• 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.

Qualifications

• 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.

Company Description

DQS Inc. is an Equal Opportunity Employer.

• Minorities/Women/Veterans/Disabled
• EQUAL EMPLOYMENT OPPORTUNITY (EEO)