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Quality Supervisor - Reagents (A Schedule)

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Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality

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Description

At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.

We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.

Come be a part of our team and our mission as a Quality Supervisor to join our growing Reagents Quality Assurance Team!

Team A schedule: 12 hour shifts Sunday-Tuesday + every other Wednesday 6:00 AM-6:30 PM.

The Quality Supervisor will assist the Associate Director of Quality, or Manager in the day-to-day management of Quality personnel to support the needs of the Reagent Manufacturing Department. The Quality Supervisor will monitor and assign out work; drive the improvement process; ensure that Quality procedures are done in compliance with applicable regulatory requirements and company policy; create, maintain, audit, and report team metrics; assist in hiring activities; ensure that only conforming product is released and goals for product turn-around times are met; assist in auditing activities of manufacturing areas to ensure audit-readiness and participate in special projects as delegated by the Associate Director of Quality, or Manager.

Principal Job Duties and Responsibilities:

  1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
  2. Achieve Quality operational objectives by monitoring and assigning day-to-day activities of Quality Specialists and Technicians to meet the needs of Manufacturing.
  3. Identify and address gaps and problems; implement change and provide regular feedback to the Supervisor regarding system performance and issues.
  4. Work closely with departmental managers to ensure employees are working in compliance with company policy and within the guidelines of BFDX’s Quality System.
  5. Create and maintain team metrics.
  6. Meet regularly Supervisor to report team metrics, set team priorities, and address staffing issues and problems.
  7. Perform hiring activities and oversee training of new and existing Quality Specialist and Technician employees.
  8. Supervise NCR Management process: review NCRs to confirm all necessary activities have been done, are properly documented, and materials have been accurately physically and electronically dispositioned; close NCRs.
  9. Supervise TCO management process: ensure proper handling of TCOs, from review and approval to expiration or implementation of change order.
  10. Supervise scheduling and performance of manufacturing area sweeps to ensure audit/inspection readiness.

Principal Decisions:

  1. Assist Quality Technicians and Specialists to ensure that only conforming product is released for distribution in the field.
  2. Determine priorities and assign daily workload to ensure support activities are being completed.
  3. Determine suitability of manufactured materials for release to customers based on manufacturing and functional testing batch records.
  4. Provide support for maintaining compliance in regards to preventative maintenance/calibration requirements of production equipment.
  5. Audit team metrics to identify areas for improvement.
  6. Work with the Supervisor to hire appropriately, ensuring that the demands of Manufacturing and target product turn-around times are met.
  7. Participate in yearly employee reviews to improve employee performance.
  8. Achieve Quality operational objectives by monitoring and assigning day-to-day activities of Quality Specialists and Technicians to meet the needs of Manufacturing.
  9. Identify and address gaps and problems; implement change and provide regular feedback to the Supervisor regarding system performance and issues.
  10. Work closely with departmental managers to ensure employees are working in compliance with company policy and within the guidelines of BFDX’s Quality System.
  11. Create and maintain team metrics.
  12. Meet regularly with the Supervisor to report team metrics, set team priorities, and address staffing issues and problems.
  13. Perform hiring activities and oversee training of new and existing Quality Specialist and Technician employees.
  14. Supervise NCR Management process: review NCRs to confirm all necessary activities have been done, are properly documented, and materials have been accurately physically and electronically dispositioned; close NCRs.
  15. Supervise TCO management process: ensure proper handling of TCOs, from review and approval to expiration or implementation of change order.
  16. Supervise scheduling and performance of manufacturing area sweeps to ensure audit/inspection readiness.

Supplemental Data: 

  • Shift supervisor who will supervise a team of 10-15 individuals.

Training and Education:

  1. Bachelors Degree in life science or engineering discipline preferred. Experience in a quality, laboratory, or medical device manufacturing position at a company that has a formal quality system (e.g. ISO 9001, ISO 13485 or GMP) may substitute for a degree.
  2. Demonstrate experienced computer skills, including high proficiency in MS Word and Excel.
  3. Required – Training in Quality Management Systems for FDA – CFR, ISO 13485, ISO 9000, and CMDR compliance.
  4. Required Training – Current enrollment or completion of ISO 9001:2008 36-Hour Certified Lead Auditor with Medical Device Focus and the Salt Lake Community College Medical Device Manufacturing Program.

Experience:

  1. Previous experience in Quality Assurance or Quality Control equivalent to mastering responsibilities of a Quality Specialist III is required.
  2. Expert level understanding of Quality Management Systems compliant to FDA – CFR, ISO 13485, ISO 9000, and CMDR in their area of work.
  3. Six years of experience in similar roles in QMS related activities preferred.

Skills:

  1. Attention to detail is fundamental to this position.
  2. Management level understanding of tools, reporting and metrics utilized by Quality Specialists.
  3. Work with teams to develop processes. Ability to create instructions and provide detailed verbal descriptions of processes.
  4. Strong organizational skills as needed to assign workload and task schedule.
  5. Development of Team Trends and Measures and upper-level understanding of statistics.
  6. Developing and improving upon procedures for Quality Assurance and advising on compliance aspects of procedures for other groups. Providing motivation for team members to follow procedures.

Physical Requirements: 

  • Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
  • Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.
  • Ability to distinguish colors.
  • Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
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