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Post-Market Surveillance Auditor

Plymouth, Minnesota 55442

Category: Professional Job Number: 15484
Voca has an immediate opening available for a Post-Market Surveillance Auditor in Plymouth, MN.

If interested, apply herein or contact rspencer at myvoca dot com. Thank you.

Position Details 
Shift: 8a-5p
Key Requirements:
  • Knowledge of medical device regulations for US, Japan, Australia, Brazil, Canada.
  • Must have knowledge of ISO 13485 (13485:2016) for Medical Devices.
  • Must have 2+ years' experience in a Lead Audit role.
Job Description:
Assist Postmarket Surveillance with closure of complaint files. 
Audit files for completeness, print documents missing from the paper files, review to ensure all documents meet good documentation practices/labeled correctly and in the designation place in the folder, electronically close the file in the complaint system. 
Collate and file the complaint folder in the designated place. Prepare documents for archival. 
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.  Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. 
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.

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