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. 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. + Inspect product (including labels) to specifications and established procedures. Determine product acceptance status after inspection. + Identify and escalate non-conformances observed during inspection. Work with production teams to resolve non-conformances where possible. + Ensure good documentation practices during quality document and quality record review. Report inconsistent or incorrect records to appropriate systems. Work with production teams to resolve erroneous records. + Physically release work in process for finished goods processing + File and archive quality records according to established processes. + Prioritize product release to meet department goals + Identify and report floor failures observed during sweeps of manufacturing areas. + Review and approve Device History Records. + Receive and hold finished goods inventory until release is authorized + Release finished goods to stock inventory + Coordinate molded part validation inventory + Confirm manufacturing equipment meets requirements for release to Manufacturing Engineering for validation. + Confirm manufacturing equipment meets specifications for release to Reagent Manufacturing for use. + Control (physically and electronically) material suspected to be non-conforming + Review Non-conforming Product Reports (NCRs) for content, accuracy, and clarity + Review and decide if rework documentation meets requirements for approval and performance. + Physically and electronically disposition NCR-related materials Supplemental Data: + Minimal domestic travel may be required for training purposes Training, Education and Experience: + 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). + 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. Knowledge, Skills, 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 write standardized and clear instructions. 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 perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed. + Must be able to perform duties in a clean room environment. This requires the use of work attire provided and laundered by the company. + 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.