Carol Stream IL
Injection Molding
Date Posted

Quality Assurance Manager


  • Serve as Quality Manager for all operations activities.
  • Supervise the Quality Inspection, QC Shipping/Receiving and Calibration Departments.
  • Supervise operations quality engineers.
  • Coordinate inspection activities to insure product and process compliance to acceptance requirements.
  • Control nonconforming product and coordinates final product acceptance/release activities.
  • Oversee operations quality involvement in process validation activities.
  • Develop, implement, and maintain quality systems to ensure FDA and ISO compliance.
  • Optimize quality systems to effectively identify, measure and reduce cost of quality activities.
  • Identify, support, and develop departmental resources to achieve business and quality objectives.
  • Actively participate in all facility audits (FDA, ISO, Corporate and Division).
  • Participate in the development of process FMEAs.
  • Review and approve all engineering changes for existing product, processes, and materials.
  • Promote and support multi-discipline teamwork.
  • Oversee establishment of manufacturing quality plans for transferring product designs to manufacturing.
  • Maintain calibration system and associated activities.
  • Manage the Material Review Board process.
  • Support existing product/process improvement programs.
  • Support new product development programs.

Required Qualifications:

  • Process validation experience, including packaging and labelling processes.
  • Technical knowledge of measuring equipment and the required calibrations.
  • Strong working knowledge of QSR, ISO 13485, MDR, ISO14971 (Risk Management), and Canadian Medical Device requirements.
  • Experience conducting quality audits (internal and supplier).
  • Experience managing and hosting external audits (e.g. FDA, ISO).
  • Strong organizational skills.
  • Strong working knowledge of statistical quality tools.
  • Strong oral and written communication skills.

Preferred Qualifications:

  • ASQ Certification (CQE, CRE, CQA, CQM) preferred.

Education and/or Experience:

  • Minimum of a four-year degree in an Engineering discipline. Mechanical or Biomedical Engineering degree preferred.
  • Minimum of 5 years’ experience in federally regulated industry to include QA, compliance, and/or Regulatory Affairs.
  • Minimum 5 years supervisory experience.

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