Quality Specialist

Description

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.

Primary Duties:

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 - see relevant Appendix section.
7. Ensure good documentation practices during document review and inspection.
8. Conduct floor sweeps (entails verification of GMP standards).
9. Create Non Conformance Reports for failing product.
10. Conduct In-Process inspections.
11. Conduct software verifications.
12. Conduct subassembly inspections.
13. Assist in implementation of WID and process changes.
14. Assist in WID and Temporary Deviation creation and updates.
15. Host meetings.
16. Training and mentoring Quality Technicians and other departmental hires.
17. Provide support to all aspects of the Quality System; provides assistance in other quality department duties and projects as assigned.
18. Follow work instruction documents to ensure batch record compliance.
19. Alert management of nonconforming events.
20. Provide support for compliance of preventative maintenance and calibration requirements of manufacturing equipment.
21. Release product based on Device History Record review.

Training/Education/Experience:

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).
5. Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
6. 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.

Physical Requirements:

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. Other Requirements - see relevant Appendix section.