Senior QA Inspector.

Job Summary

This position is responsible for inspecting, testing, and auditing of raw materials and finished product, as well as releasing finished product.

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 to ensure accuracy and completeness per procedures. 
3.  Inspect and release raw materials, components, sub-assemblies, and finished devices according to procedure. 
4.  Log in non-conformances and assist in investigations as appropriate. 
5.  Provide training assistance when needed. 
6.  Provide production with assistance when needed. 
7.  Prioritize workload and flow through areas to meet production and customer needs. 

Job Responsibilities (continued)

8.  Complete first article inspections as needed. 
9.  Perform preventive maintenance as needed. 
10. Assist in planning and implementing of projects to develop, install, and qualify new process for manufacturing of new products or improving existing processes. 
11. Gather and analyze data to suggest improvements. 
12. May include training of new Associates. 
13. Identify and drive improvements in other inspection areas. 
14. Designated individual for Label Inspection as needed for Ann Arbor site. 
15. Perform other duties as assigned.

Working Conditions/Physical Requirements

The position exists in a production and/or warehouse environment. May require gowning procedures for controlled environment. 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. 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 and a minimum of two years of experience in quality assurance or manufacturing. Intermediate computer software skills, i.e. Microsoft Office. Prefer ASQ Certified Quality Inspector certification.