Quality Specialist

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

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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Description

This is a full-time, hourly position that provides support through inspection of raw materials. As a Quality representative, the employee will assess and monitor both process and product. Timely and accurate work as well as a high level of self-direction and motivation is expected. Regular cross functional interaction and collaboration with attention to detail is required.Work is fast paced and requires prioritization of daily tasks. Effective communication, written and verbal, is critical.

Description

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

Training and Education

• High school diploma or equivalent is required
• Associate degree (or higher) in a life science or engineering discipline is preferred.
• Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required
• 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) is preferred.

Experience

• Minimum... For full info follow application link.

#Manufacturing