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Quality Assurance Manager

  • Ref: 300071
  • Type: Direct Hire
  • Location: Parsippany, NJ
  • Industry: Medical Devices
  • Job Level: Manager
  • Pay: $100,000 - $135,000 plus Bonus

Opportunity Description

The Quality Assurance Manager who will own responsibility for implementing and managing the QMS system and all quality areas for the Company, a medical device distributor and field service provider.  Initial focus of the QMS system will be on our imported consumables, followed by our rebuilt equipment and field service. 

Company Information

Medical device/products

Job Duties

  • Develop, implement, manage and document a quality management system in conjunction with FDA requirements under CFR 21 Part 820
  • Establish and execute internal quality audit processes
  • Develop, document and institute recall procedures
  • Create SOP’s for the retention of quality records, device history records and overall record retention
  • Handle both customer and supplier complaints and reporting, including CAPA and SCAR documentation
  • Participate in product development processes, conduct quality reviews
  • Review and maintain supplier and manufacturer quality, including new vendor approvals
  • Develop and maintain key vendor quality KPI’s and scorecards
  • Coordinate all aspects of the regulatory process and approvals
  • Monitor corporate-wide compliance with quality standards
  • Train staff on SOP compliance as required
  • Ensure labeling and packaging requirements are met and consistent 
  • Serve as lead contact for all communications with FDA
  • Prepare for and lead customer quality assurance audits
  • Prepare and send customer communications as needed e.g. quality control letters
  • Complete and respond to customer survey requests
  • Develop and report on Quality KPI’s
  • Serve as the “Quality Champion” to promote a culture of quality at all points in the Value Stream
  • Review performance breakdowns in all departments, coordinate improvement efforts
  • field service recall visits, shipping errors, order processing errors, product non-conformances, equipment warranty failures, any other customer complaints

Education

BA in Business Administration minimum; BS or higher in Quality Management preferred

Experience & Skills Required

  • A minimum of 8-10 years’ experience in the quality arena, medical device experience strongly preferred
  • Experience with Quality Control in distribution environments
  • Experience working closely with new product development teams
  • Experience in developing policy and procedure and carrying through to implementation
  • Expansive knowledge, experience and understanding of FDA requirements under CFR 21 Part 820 and/or ISO 13485:2016
  • Experience and knowledge of products subject to FDA 510(K) regulations a plus 
  • Strong communication skills and superior attention to detail
  • Creative thinker who can maintain quality control while also considering the needs of the business

Other Information

INDWP