Minneapolis MN 55430 USA
We are TPI Custom Solutions, a 13485 certified manufacturer of custom sewn and fabric welded products for the medical industry. Working collaboratively with our customers to develop solutions, we build products that save and improve lives. Founded in 1981, our business is booming, and we have an exciting growth opportunity for a Quality Assurance Supervisor interested in a position moving towards a Quality Manager role. TPI Custom Solutions is located in Minneapolis near Highway 100 and 49th Avenue North.
Our new Quality Assurance Supervisor will be an integral part of supervising our quality inspection team and managing our 13485 certification. This role leads internal audits, annual full system audits and supports our quality system by gathering data and maintaining required documentation. We seek candidates with an eagerness to learn and implement and improve quality systems. Specific duties include:
- Maintain 13485 certification and ensure company-wide quality conformance through problem prevention, troubleshooting, testing, writing, auditing, updating and maintaining quality procedures
- Identify quality problems, initiate actions, make recommendations and verify implementation of solutions
- Provide input during product development from a quality standpoint
- Maintain MRB and CAPA process including customer complaint log
- Train production personnel in all aspects of the quality program
- Supervise and direct QA staff in day to day operations
- Conduct scheduled department level meetings with all QA staff
- Point of contact for customer audits preparing and submitting quality surveys, ensuring all required documentation is generated
- Ensure vendors/suppliers meet quality requirements
- Lead Continuous Improvement, 5S and Lean projects, as needed
- Gain detailed knowledge of the overall business operation, its organizational procedures, and personnel
- Assist in special projects, as required
We seek a Quality Assurance Supervisor with 2 - 5+ years of experience in a 13485 or ISO Certified environment. Past job experience as a Quality Lead, Quality Engineer, Quality Supervisor or similar, should include performing audits in support of ISO renewals, documentation and report generation and reviewing and implementing quality procedures. Experience in a short-run, custom manufacturing environment, helpful. ASQ certification (or similar) along with an Associates or Bachelor’s degree in Quality or Manufacturing, highly desirable. Intermediate MS Word and MS Excel skills are required.
Please forward your resume to our hiring resource, Red Seat: email@example.com Red Seat is not a recruiter or employment agency, but a contract HR company assisting us in the hiring process. For more info, call Red Seat direct at (612)-405-2574. We will confirm receipt of your resume within two business days.