- 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.
- 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.
- 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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