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. GR&R 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 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
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
5 years combined above experience is preferred
Skills & Qualifications:
Preferred specialized expertise such as IPC610 and/or IPC620 certified, GD&T background, problem solving, technical writing, black belt.
Effective written and verbal communication skills
Proficiency in MS Office tools, including Outlook, Word, and Excel
General computer operation
Attention to detail is fundamental to this position.
Ability to accurately follow written and verbal instructions.
Organization skills as needed to maintain paperwork and task schedule.
Proficiency in internet navigation
Basic math proficiency
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:
Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility
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.
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