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BioFire Diagnostics, LLC. Quality Technician III - C Schedule in Salt Lake City, Utah

BioFire Diagnostics, LLC. is looking for a Quality Technician III to join our growing BioReagents Quality Assurance Team. Position Summary:

This is a full-time hourly position. Quality Technician IIIs are mid-level quality technical personnel. They understand the QMS in their assigned areas but do not necessarily understand the QMS in other company functions.

This individual will perform quality control reviews of manufactured products and manufacturing records. The work is performed in real-time and in accordance with the Quality System. Timely and accurate work are expected. The work is fast-paced and employees in this role are expected to complete a list of tasks.

This position regularly interacts and/or collaborates with other departments within BioFire. Position follows standard work practices and procedures, normally receives little or no instruction on day to day work and detailed instructions on new assignments.

PLEASE NOTE: Beginning January 3, 2021, the working schedule for this position will be Sunday - Tuesday + Every Other Wednesday 6:00 PM - 6:00 AM.

Principal Job Duties and Responsibilities:

  • Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.

  • Ensure process compliance, as needed. Report on process compliance where appropriate. Participate in process development.

  • Report observations to supervisors using established metrics. Evaluate metrics for trends.

  • Provides assistance in other QA department duties and projects as assigned.

  • Review and approve Device History records. Release work in process to finished goods inventory. Report inconsistent or incorrect records to appropriate systems. Report errors to supervisor. Work with production teams to resolve erroneous records.

  • Inspect product to specification or process. Report non-conforming product to appropriate systems. Report errors to supervisor. Work with production teams to resolve non-conformances where possible.

  • Physically quarantine non-conforming products. Transact the quarantined materials in appropriate systems. Used established metrics to report on non-conforming products to managers and supervisors.

  • Performs QC testing as needed. Mastery of elementary test methods is expected. Report test results using established metrics.

  • Determination of product acceptance status after inspection.

  • Identification and escalation of non-conformances observed during inspection.

  • Ensure good documentation practices during document review and inspection.

  • Identify, report, and track floor failures observed during sweeps and/or inspections.

  • Prioritization of product release to meet departmental goals.

Principal Decisions:

  • Review and analysis of Device History Records (DHRs) to confirm the presence, accuracy, and completeness of all quality records associated with the manufacture of product in Reagent Manufacturing.

  • Evaluation of acceptance status activities to ensure that only conforming product is released for distribution.

  • Prioritization of final product release to maintain inventory levels and avoid product backorders.

  • Assessment of fitment and plunger functional testing data and specifications for the release of conforming parts to Reagent Manufacturing or generation of an NCR for investigation and disposition of non-conforming parts or processes.

Supplemental Data:

This is a mid-level position within the company. The employees are expected to understand the role of their team and activities of team members.

Training and Education:

  • Associates 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.

  • Demonstrate good computer skills, including proficiency in MS Word and Excel.

  • Current enrollment or completion of the Salt Lake Community College Medical Device Manufacturing Program.

Experience:

  • Previous experience in Quality Assurance or Quality Control equivalent to mastering responsibilities of a Quality Technician II is required. A Bachelors degree many substitute for this experience.

  • On-the-job experience sufficient to ensure professional communication and interactions.

Skills:

  • Attention to detail is fundamental to this position.

  • Ability to accurately follow written and verbal instructions.

  • Organization skills as needed to maintain paperwork and task schedule.

  • Effective communication skills

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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