ISO 13485 Lead Auditor
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Portland, ME 04101
Local Unit & Position Description
DNV GL – BUSINESS ASSURANCE NORTH AMERICA is seeking an ISO 13485 LEAD AUDITOR. THE ISO 13485 LEAD AUDITOR partners with clients in the Medical Device industry to improve the quality and safety of their business performance through the application of internationally recognized standards.DNV GL Business Assurance North America is a leading provider of accredited management systems and product compliance certification.
We offer a broad portfolio of services across a variety of disciplines and industries. Our auditors are generally based remotely allowing them to work independently as they travel to client sites while receiving a full complement of administrative support from our central office in Katy, TX.
TASKS MAY INCLUDE
- On-site and off-site technical assessments of Medical Devices against Medical Device Directive
- Perform 3rd party on-site ISO 13485 (Medical Device) audits for North America customers
Schedule and plan audit activity with customers* Interact directly with customers at all levels of management in developing timely, complete and accurate reports of their current level of compliance or implementation of their management system
- Document and report audit activities and results
- Provide timely and accurate reviews of customer corrective action and closure
- Maintains appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed
- Must have a Bachelors Degree or higher in biology or microbiology; chemistry or biochemistry, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics or other related fields
- Must have a minimum of 4 years experience in the medical devices industry
- Must be currently approved as a competent Lead Auditor for ISO 13485 by a Certification Body Third Party certification Lead Auditor (NO Exceptions)
- Must have a minimum of 1 year o…