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 Senior Quality Technician 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. 

1. Perform all work in compliance with company policy and within the guidelines of its Quality System.
2.  Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
3. May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned. 
4. Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
5. May present project related information to management as requested.
6. Other Duties  as asigned

 Supplemental Data 

1. Minimal domestic travel may be required for training purposes  

Training and Education 

1. High school diploma or equivalent is required.
2. Associate degree (or higher) in a life science or engineering discipline is preferred. 
3.  Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required. 
4. 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).

Experience 

1. Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.  
2. 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. 

Knowledge, Skills, and Abilities 

1. Effective written and verbal communication skills.
2. Proficiency in MS Office tools, including Outlook, Word, and Excel.
3. General computer operation.
4. Attention to detail is fundamental to this position. 
5. Ability to accurately follow written and verbal instructions. 
6. Organization skills as needed to maintain paperwork and task schedule. 
7. Proficiency in internet navigation. 
8. Basic math proficiency. 
9. Ability to write standardized and clear instructions. 

Working Conditions and 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. 

1. Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.  
2. 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). 
3. Maintain Quality System data.
4. Triage document number requests from Quality Web. 
5. Assist employees in obtaining identification numbering for controlled documentation.
6. Scan old and new records for maintenance and traceability. 
7. Verification of scanned documents on Quality Web. 
8. Verify unique identifiers for software discs, batch record discs and labels.
9. Post documents to document database from the local network drive. 
10. Post approved Quality Web documents to the internal database. 
11. Provide basic guidance on QMS processes. 
12. Triage document check-out requests for updates. 
13. Prioritizes record retrieval based on situational needs (e.g. external/internal audits) 
14.  Ensure proper individuals have approved documentation 
15. Create controlled copies of USBs/discs. 14. Assist in addressing basic QMS questions. 
16. Assist other team members in special projects.
17. Troubleshoot QualityWeb issues.
18. Update departmental WIDs (work instruction documents)
19. Assist in projects and meetings as directed by the Document Control Manager 
20. Process change orders/temporary change orders for implementation into the Quality system 
21.  Train and mentor Quality Technicians on document control procedures 
22. Update departmental WIDs and SOPs to ensure best practices are being followed.
23. Identify and escalate nonconformance’s observed during review. 
24. Identify need for new document control processes and procedures. 

Skills & Qualifications

Demonstrated ability for independent quality-based decision making within the QMS and Quality Document Tools