Quality Specialist

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. 

• 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.