Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality
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 Specialist I!
This is a full-time, hourly position that provides manufacturing support through inspection of raw materials. Quality Specialists are in the mid-level range of quality technical personnel. This position requires a high level of self-direction and motivation.
This individual may work on quality improvement projects, monitor NCR’s and associated activities, revise existing procedures, train and mentor Quality Technicians, process change control and implementation orders, and perform specialized inspections for raw materials.
Timely and accurate work is expected. This position regularly interacts and collaborates with other departments within BioFire. The work is fast paced, requires prioritization of daily tasks, and attention to detail. Effective communication, written and verbal, is critical.
PRINCIPLE JOB DUTIES AND RESPONSIBILITIES
Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
As a Quality representative, employee will be responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
Perform inspection of incoming materials using basic and advanced measurement tools
Perform quarantine activities including physical and electronic segregation, labeling, physical and electronic release
Investigate and manage NCRs including investigation, additional testing, test analysis, disposition, and ERP inventory management reconciliation
Complete first article inspections
Perform and manage rework activities to completion
Initiate and author WID updates
Support/interact with Materials Management, Engineers, and Purchasing including all requested research history, SCAR follow through, special projects, etc.
TRAINING AND EDUCATION
High school diploma or equivalent is required
Associates degree in life science or engineering discipline preferred.
Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required Completion of Medical Device Manufacturing Certificate program (provided by BioFire after hire is required. Equivalent certifications may be considered in lieu of this certification (e.g. Six Sigma Green Belt, ASQ CQT
CMM experience, IPC620, and/or GD & T certification preferred
Work experience in a laboratory or life science manufacturing setting that has a formal quality system is required.
For External Candidates: Minimum 4 years’ experience where reviewing, assessing and monitoring process and product compliance to standards was a primary job function. Education may be considered in lieu of experience.
For Internal BioFire Candidates: Mastery of Quality Technician III principle duties, responsibilities, and decisions or equivalent external job experience required; education may be considered in lieu of experience.
Effective written and verbal communication skills
Proficiency in MS Office tools, including Outlook, Word, and Excel
General computer operation
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.
Proficiency in internet navigation
Ability to write standardized and clear instructions
Ability to effectively train, mentor, and coach others
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.
Must be able to travel (if required for training).
Perception of and ability to distinguish colors