Quality Manufacturing Manager


Quality Manufacturing Manager

  North Carolina,
6 days ago
Permanent/Fixed Term

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Manager, Quality Manufacturing

A fast-paced medical device company at the cutting edge of innovation in coagulation and hemostasis testing is looking for there next quality manufacturing manager. Creating the next generation point-of-care test solution to guide the management of critical bleeding in acute and critical care settings. 

The Manager, Quality Manufacturing has overall responsibility for the management manufacturing quality to meet the company’s business needs.



  • Ensure proactive compliance to federal regulations and standards including compliance with all Food & Drug Administration (U.S.FDA) and European Union In Vitro Diagnostic Directive (IVDR) as well as all other applicable regulatory requirements.
  • Identify gaps in manufacturing GMP compliance as well as impact of changing regulations or industry standard.
  • Serve as Validation SME for production-based validations. 
  • Serve as Quality Systems First Article SME for production raw material and components. Assist owners in generation of FAI and serve a QS review and approval of First Article Inspections (FAI).



  • BS/BA or equivalent experience in Engineering, Biological/Life Sciences, Chemistry, or related field required. 
  • 7+ years of experience in Manufacturing Quality, 2+ years of experience with IVD manufacturing processes and procedures; including acceptance activities, production and process controls, identification, and traceability, etc.
  • Experience applying quality regulations and standards (21CFR 820, ISO13485).
  • FDA regulated environment experience
  • Significant experience and understanding of manufacturing quality processes within the medical device/in vitro diagnostics device industry with an analytical and organized approach. 
  • Knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDR or MDD, CMDCAS, SFDA, JPAL, ISO 13485:2016, ISO 14971, or other applicable standards and regulations. 
  • Experience and competence in leadership of project teams and facilitation of team meetings.


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+44 (0) 20 3589 9300

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