Job Opening – Quality Specialist III

BioFire Defense is an Equal Opportunity Employer (M/F/D/V).

Position

Quality Specialist III Posted: 12/11/19

Status

Department

Full-Time Quality Assurance

Position Summary:

  • BioFire Defense is seeking a Quality Specialist III to join our team. The Quality Assurance (QA) Specialist III is a member of the QA department. This QA Specialist will be responsible for the day-to-day maintenance of the Quality Assurance process for Corrective Action and Preventive Actions (CAPA) initiation, investigation, and maintenance. They will monitor, review and track documented failures through various quality systems including (but not limited to) the NCR tracker, customer complaints, audit findings, out of specification trending, management review, etc. They will work with a Quality Assurance Manager and other key stakeholders in the prompt resolution of significant quality issues. This includes taking necessary corrective and preventive action when non-conformances in the product, processes, and/or services are identified. Will work with QA management to identify and analyze trends in productivity and quality.  Responsible for trend delivery and review, and contributes to Management Review. Performs a variety of tasks as assigned by QA Managers. The QA Specialist III may also assist with meeting internal expectations for accuracy and turnaround times for other Quality Assurance Activities.  Quality Assurance activities may include internal audits, calibration and preventive maintenance, and document control. This position requires Quality Assurance background with strong computer skills, excellent attention to detail, and proven experience with Quality System functions. Project management skills are essential to success.

 

Training and Education:

  • College degree preferred (science or engineering major). Appropriate college level classes plus additional experience in QA or manufacturing field can substitute for degree.
  • ISO 13485 Lead Auditor Training (may be obtained on the job also).

 

 Experience:

  • Minimum 2 years of experience in device or pharmaceutical or biotechnology QA or manufacturing.

 

Supplemental Data:

  • A Quality System is mandated by the BioFire Defense policy and the company’s commitment to sell only products of consistently high The QA department’s responsibility is to develop and maintain such a system company-wide. A key function of this position is to maintain this company’s focus on excellence.
  • This position requires excellent computer and database skills and attention to detail.
  • Knowledge of a broad range of Quality System and statistical principles, methods, and practices is required to facilitate appropriate decision-making, and recognition when additional expertise is needed to solve problems.
  • Position requires an in-depth knowledge of regulatory requirements for manufacturers of medical devices and applicable contractual requirements affecting BioFire Defense’s Quality System.

 

Benefits/Compensation:

  • We offer competitive salaries
  • Matching 401k
  • Vacation/holiday pay
  • Medical benefits
  • Stimulating work environment

If you are interested in this position please send us your resume and contact details through one of our job boards at:

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Our EEO Policy

BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.