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Quality Auditor – Supplier Audit

Location: Salt Lake City, UT, United States
Job Function: Quality

Description

Job Summary

The Quality Assurance department provides quality support across various departments within BioFire. The department is organized into distinct subunits, consisting of Calibration & Preventive Maintenance, Document Control, Reagent Manufacturing, Instrument Manufacturing, Servicing, Incoming Material QC, QMS Project Management & Auditing.

Works under the direction of the Associate Director of QA to support QMS Project Management and Auditing, and will be responsible for supporting and coordinating all efforts associated with external supplier quality auditing activities.

Supports the Quality Department in performing external audits, preparing supplier audit plans and schedules, arranging supplier audit activities, and providing summary reports of findings. Collaboration with Purchasing, Engineering, and Quality teams is fundamental to this position.

Supports the Director and Associate Directors of QA in external audit activities and may provide internal audit support as needed.

 Essential Job Duties and Responsibilities

  1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
  2. Establish supplier audit schedules and activities.
  3. Perform gap analysis of supplier QMS to new and existing regulations and standards.
  4. Present supplier audit findings at annual Management Review meeting.
  5. Present supplier audit findings and OFI’s to Supplier Program Manager, and members of Supplier Review Board/Material Review Board.
  6. Understand company organization, operations, product development cycle and management processes.
  7. Understand QMS organization and QA functions.
  8. Maintain supplier audit finding database (SCARs).
  9. Evaluate supplier audit findings and opportunities for improvement.
  10. Review supplier audit findings and opportunities for improvement for trends over time.

Supplemental Data

Information that will enhance the understanding of the nature of the job (e.g., number of people directly supervised, total staff supervised, sales volume impacted, operating budget, extent of travel required, etc.)

  1. 5-10% Domestic and/or international travel may be required for training purposes
  2. 25-75% domestic and/or international travel may be required for performing supplier audits

 

Note: Travel may be restricted during times of high risk to travelers.  Supplier audits may be performed remotely as deemed necessary by management.

Qualifications

Training and Education

Minimum education and/or training requirements for this position (i.e. high school diploma, college degree, and/or certification).

  1. Bachelor of Science or Master’s Degree (science, engineering or life sciences).
  2. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required.
  3. Knowledge of quality principles and regulations applicable to in vitro diagnostic products, including FDA QSR, ISO 13485, CMDR, CE Marking, ISO 9001, ISO 14971, In Vitro Diagnostic Directive/In Vitro Diagnostic Regulation.
  4. Knowledge of MDSAP audit program a plus.

Experience

Minimum time and type experience required for this position.

  1. Minimum 5 years work experience in Medical Device, Pharmaceutical or Biotechnology manufacturing setting that has a formal quality system is required.
  2. Auditing experience in Medical Device, Pharma, or Biotechnology industry.

Knowledge, Skills and Abilities

Knowledge, special skills and/or abilities required to perform the job functions (e.g., negotiation, technical writing; statistical evaluation).

  1. Effective written and verbal communication skills
  2. Proficiency in MS Office tools, including Outlook, Word, and Excel
  3. General computer operation
  4. Proficiency in internet navigation
  5. Attention to detail is fundamental to this position
  6. Strong organization is required
  7. Auditing principles and best practices
  8. Ability to accurately follow and interpret written procedures
  9. Ability to accurately comprehend and interpret federal and international regulations and standards
  10. Excellent communication skills, both oral and written
  11. Excellent collaboration with cross-departmental leaders within the organization
  12. Professional communication and peer-to-peer interactions a must
  13. Critical listening skills
  14. Experience with MS Visio a plus
  15. Ability to prepare clear and concise summaries for executives and stakeholders
  16. Strong presentation skills

Physical Requirements

List any special physical requirements needed to perform the job, such as ability to lift specific weight. List “None” if there are no special requirements.

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.

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ 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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