Sr Quality Specialist

Description

Position Summary

The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC. Depending on the sub-unit, Quality Specialists may work on quality improvement projects, monitor NCR’s (including associated activities), revise existing procedures, train and mentor QA personnel, manage CAL/PM systems, process change control and implementation orders, and perform specialized inspections for raw materials. This position builds upon the skills and responsibilities of a Quality Specialist and requires an increased level of self-direction and motivation. This position requires a high level of self-direction and motivation. Timely and accurate work is expected. This position regularly interacts and collaborates with other departments. The work is fast paced, requires prioritization of daily tasks, and attention to detail. Effective communication, written and verbal, is critical.

Primary Duties

• 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.
• Work cross-functionally to design new processes as needed
• Other Duties – see relevant Appendix section.
  
  

Sumpplemental Data

• Minimal domestic travel may be required for training purposes
  
  

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
• Completion of 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).
  
  

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.
  
  

Knowledge, Sills and Abilities

• 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 develop and write standardized and clear instructions.
  
  

Working Conditions And Other Physical Requirements

• Ability to remain in stationary position, often standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
• Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation. Must be able to travel (if necessary).
• Perform inspection of incoming materials using basic and advanced measurement tools
• Perform quarantine activities including physical and electronic segregation, labeling, physical and electronic release
• Perform second person verifications
• Initiate NCRs with a thorough description of the nonconformance including target as well as discrepancy, quantity and standard used for rejection. Support investigation activities.
• Complete first article inspections.
• Perform and manage sorting activities to completion
• Identify, initiate, and author WID updates
• Support and/or manage validation testing, e.g. GR&R and program validations.
• Develop first draft of Technical Review
• Write validation protocols
• Input data into MiniTab and work with Engineering on analysis of validation data
• Initiate, author, and generate CO for IC documents
• 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 and specialists
• Initiate routines and programs for metrology tools under engineer guidance; develop first draft of Tech Review
• Coordinate activities for metrology tool calibration
• Ensure compliance to Temporary Change Orders’s; 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
  
  

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.
  
  

Skills & Qualifications

• Preferred specialized expertise such as IPC610 and/or IPC620 certified, GD&T background, problem solving, technical writing, black belt.
• Demonstrated skill set and knowledge of inspection methodologies and techniques through competency testing during the interview process.