Quality Assurance Technician.

Job Summary

This position is responsible for inspecting, testing, and auditing of raw materials and finished product, as well as releasing finished product in accordance with documented procedures and processes.

Job Details/Responsibilities

1.  In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 
2.  Compile, verify, and review Device History Records (DHRs / EDHRs) to ensure records are complete and correct. Escalate issues to non-conformance report as necessary.
3.  Perform pre-sterile and post-sterile inspection of products according to procedure.
4.  Inspect and release raw materials, components, sub-assemblies, and finished devices according to procedure.
5.  Review (DHRs/EDHRs) and update with associated paperwork, separate into loads for release purposes.
6.  Verify, test, and release finished product per procedure.
7.  Inspect and release raw materials according to procedure.

Job Responsibilities (continued)

8.  Process and investigate non-conformances and reworks according to procedure. Process deviations and quality bulletins according to procedure.
9.  Provide assistance with training to production or quality management Associates when needed.
10. Provide production with assistance when needed.
11. Perform additional responsibilities, as needed, which may include: Updates to customer complaint travelers, stability testing, raw material issues, Bioburden/LAL sample preparation,  other quality reporting, and environmental monitoring. 
12. Prioritize workload and flow through assigned areas to meet production and customer needs.
13. Investigate customer complaint/not complaint disposable products as required.
14. Initiate change orders as necessary.
15. Perform other duties as assigned.

Working Conditions/Physical Requirements

The position exists in office, production, and/or warehouse environments with minimal exposure to automated equipment. May require gowning procedures for controlled environment. May involve exposure to bovine and/or human blood, requiring the use of protective equipment. May at times involve exposure to chemicals requiring the use of personal protective equipment. May require the use of eye protection, hand protection and depending on noise level, may require hearing protection. 

Visual acuity in compliance with site specific Visual Acuity Program. Majority of workday is spent either standing or sitting. On occasion, may stoop, bend, reach, pull, etc. Typically includes frequent lifting of up to 10 lbs. and occasional lifting up to 50 lbs. Requires travel up to 10%. This position is not eligible to work remotely. This may change based on job responsibilities, project/business needs and/or Associate job performance.  In all cases Associates may need to have on-site presence for designated meetings and compliance related activities.
 

Knowledge, Skills and Abilities (KSA)

Qualifications/ Background Experiences

Requires a high school diploma or equivalent. A minimum of two years of prior quality assurance or manufacturing experience preferred. Basic computer software skills, i.e. Microsoft Office.