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Quality Specialist

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

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

Job Duties and Responsibilities

  1. Perform all work in compliance with company policy and within the guidelines of its Quality System.
  2. Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
  3. May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
  4. Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
  5. May present project related information to management as requested.
  6. Perform inspection of incoming materials using basic and advanced measurement tools
  7. Perform quarantine activities including physical and electronic segregation, labeling, physical and electronic release
  8. Initiate NCRs with a thorough description of the nonconformance including target as well as discrepancy, quantity and standard used for rejection
  9. Complete first article inspections.
  10. Perform and manage sorting activities to completion
  11. Identify need for WID updates and initiate WID updates
  12. Support and/or manage validation testing, e.g. GR&R and program validation activities.
  13. Initiate and author IC documents (Inspection plan)
  14. Support/interact with Materials Management, Engineers, Purchasing, and suppliers. This includes research activities and special projects.
  15. Perform sweeps of warehouse area to ensure cGMP compliance with a lead auditor
  16. Review co-worker completed inspection records
  17. Mentor technicians
  18. Initiate routines and programs for metrology tools under engineer guidance
  19. Coordinate activities for metrology tool calibration
  20. Ensure compliance to Temporary Change Orders; manage expiration status
  21. Interpret and utilize SPC chart data
  22. Analyze trends and participate in metrics development
  23. Participate as a subject matter expert in internal and external audits of the Incoming Inspection team.
  24. Write validation protocols
  25. Input data into MiniTab and work with Engineering on analysis of validation data

Training and Education

  1. High school diploma or equivalent is required
  2. Associate degree (or higher) in a life science or engineering discipline is preferred.
  3. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required
  4. Enrollment in the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g. ASQ certification; Six Sigma certification; life science or engineering related college degree) 

Experience

 Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.

  1. Minimum additional 2-year experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system. Education/certification in Quality Management Systems may be used in lieu of 1-year of this experience

Skills & Qualifications:

  1. Preferred specialized expertise such as IPC610 and/or IPC620 certified, GD&T background, problem solving, technical writing, black belt.
  2. Effective written and verbal communication skills
  3. Proficiency in MS Office tools, including Outlook, Word, and Excel
  4. General computer operation
  5. Attention to detail is fundamental to this position.
  6. Ability to accurately follow written and verbal instructions.
  7. Organization skills as needed to maintain paperwork and task schedule.
  8. Proficiency in internet navigation
  9. Basic math proficiency
  10. Ability to write standardized and clear instructions 

Demonstrated skill set and knowledge of inspection methodologies and techniques assessed through competency testing during the interview process.

Physical Requirements:

  1. Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility
  2. Must be able to push, pull, bend, and/or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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