Quality Engineer

Work for a leading Medical Company near the Twin Cities!

  • Coon Rapids, MN
  • $65,000 - $90,000
  • Managed by Jobot Pro: Sanoj Allen
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A bit about us:

We are a leading medical device manufacturer of minimally invasive surgical components with strong positions in spine and other attractive healthcare end-markets.

We have two manufacturing facilities totaling 100,000 square feet.


Why join us?

We offer a competitive benefits package including medical, dental, vision, long and short-term disability, group life, 401K, vacation, and holidays!

Job Details

1. Develop new process / products, or the Products revision, create/update project-specific quality plans, including establishing quality requirements and standards for projects, while adhering to the customer requirements and working as part of a cross-functional team.
2. Participate and be the QA lead for validation of new product and technology (IQ, OQ, PQ).
3. Interface with customers and suppliers to collaborate on the development of new product processes.
4. Compile and analyze statistical data in order to assess process capabilities and control processes and conduct Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&R) and Statistical Process Control (SPC) studies. Statistics SME.
5. Create and maintain Quality System documentation, as defining quality plans for the facility, inspection and control plans, inspection work instruction.
6. NCR, CAPA, customer complaint management from creation to closure, in respect to due dates defined and using problem-solving tools when applicable.
7. Participate and act as the QA lead for the equipment validation.
8. Participate and act as the QA lead for changes that will occur in production, in respect with Customer Agreement, ISO standard and internal requirements. Prepare, submit and follow Change Request (SCR) with customers.
9. For the Quality topics, assisting production and participating to achieve the APU objectives defined with Production.
10. Participle and generate Quality KPI for PSM2.
11. Perform internal or external audits.
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Job Details
Managed by Jobot Pro
Location
Coon Rapids, MN
Job Type
Permanent
Compensation
$65,000 - $90,000