Job Opening – Quality Specialist II – NCR/DHR

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

Position

Quality Specialist
Posted: 2/4/2021

Status

Department

Full-Time Quality Assurance

Position Summary:

  • This position is a full-time non-exempt position. The Quality Specialist provides support and helps administer the Quality System. The Quality Specialist assists with administration and maintenance of the non-conformance reporting program. The Quality Specialist also performs Device History Record review on manufactured product. The Quality Specialist is responsible for administration and completion of activities related to the quality management system. Other responsibilities include assisting with activities related to the equipment calibration and preventive maintenance program, performing sweeps of manufacturing, and assisting with internal auditing. This position requires strong computer skills, good attention to detail and experience with quality system functions. Project management skills are essential to success.

 

Principal Job Duties and Responsibilities:

  • Perform all work in compliance with company policy and within the guidelines of BioFire Defense Quality System.
  • Administer and maintain the Non-conformance report (NCR) program.
  • Perform Device History Record review of manufactured product.
  • Provide guidance and training to other departments in relation to Quality System programs.
  • Provides back-up support for QA functions.
  • Maintains Quality System data and prepares reports.
  • Special projects as requested.
  • Upon training, perform internal audits to the QSR and ISO standards applicable to the company.

 

Training and Education:

  • College degree preferred, High School diploma with experience is acceptable.
  • Must have good written and oral communication skills.

 

 Experience:

  • Be able to safely lift and maneuver up to 50 pounds.
  • 3+ years of formal Quality System experience (e.g., ISO 9000 or GMP/ISO 13485 Quality System) including experience in QC activities preferred.
  • 1+ year of manufacturing/operations experience or a degree in scientific or engineer discipline is preferred.

 

Skills:

  • Demonstrated database, spreadsheet, and word processing skills.
  • Project management skills, including monitoring and coordinating multiple activities and ability to meet deadlines.
  • Understanding of some basic QC and/or Six Sigma skills, such as Control, Run, and Pareto Charts, Histogram, Scatter Plot, Gantt Chart, Fishbone Analysis, Affinity Diagram, or Process Capability.
  • Negotiation skills required to act as liaison between R&D, Engineering, and QA and advocate for the Quality System.

 

Benefits/Compensation:

  • We offer competitive salaries
  • 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.