Sr. Medical Device Auditor

1 week ago


Dallas, United States Insight Global Full time
Job DescriptionJob Description

Job Description: Insight Global is seeking a Sr. Medical Device Auditor to join the business assurance group for one of our Inspection and Certification clients. This position will be responsible for conducting audits related to the production of medical devices for ophthalmology. The day to day includes meeting with senior decision makers at client sites, assisting with preparation and maintenance of ISO certifications (ISO 13485, MDSAP, MDD and MDR standards), and assessing policies, procedures, and records to ensure compliance standards are met. This person will be travelling a minimum of 80% of the time both domestically and internationally (weekend travel as needed).

 

Qualifications

 

Education and Experience

  • Bachelor’s degree in a related discipline (i.e., Engineering, Bioscience, Biomedical, Science, etc.)
  • Experience auditing for ISO 13485, MDSAP, MDD and MDR standards.
  • Possesses Auditor Credentials for either of these standards: ISO 13485, MDSAP, MDD and MDR

 

Travel

  • Travels up to 80% of the time (automobile & airplane).
  • Some travel may be international with flights of 8+ hours depending on the destination.
  • Weekend travel may be necessary to meet utilization requirements.


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