"Alerted.org

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, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventative maintenance on tools and equipment, and/or maintain Quality system documents. Timely and accurate work is expected. This position builds upon the skills and responsibilities of a Quality Technician and requires an increased level of self-direction and motivation. This position regularly interacts and collaborates with other departments within the company.

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.

+ Verify documentation (DHR review) and upload to BioFire Diagnostics Quality System.

+ Ensure good documentation practices during document review and inspection.

+ Conduct floor sweeps (entails verification of GMP standards).

+ Create Non Conformance Reports for failing product.

+ Conduct In-Process inspections.

+ Conduct software verifications.

+ Conduct subassembly inspections.

+ Follow work instruction documents to ensure batch record compliance.

+ Assist in implementation of WID and process changes.

+ Alert management of nonconforming events.

+ Provide support for compliance of preventative maintenance and calibration requirements of manufacturing equipment.

+ Identify opportunities for process improvement

+ Release product based on Device History Record review.

Supplemental Data:

+ Minimal domestic travel may be required for training purposes

Training, Education & 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.

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

+ Minimum additional 1-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 this experience.

Knowledge, Skills, & Abilities:

+ Demonstrated ability for independent quality-based decision making within the QMS

+ 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.

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.

+ Ability to adjust or move objects up to 25 lbs. in all directions. 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).