Supplier Quality Engineer

Saint Paul, MN
Oct 12, 2017
Jan 03, 2018
Ware Technology Services
Job Type
Employment Status
Full Time
We are seeking a Supplier Quality Engineer with experience in the med device industry for a long term contract with a company in the northeast metro. In this role you will act as the point of contact within the group for all strategic issues relating to supplier and/or contract manufacturer performance and improvement activities. You will also partner with suppliers/contract manufacturers and external customers, maintain necessary controls and drive improvements relating to component/device quality in conjunction within the suppliers’ quality systems. The ideal candidate has a B.S. related to Engineering or Science, have 2+ years experience in the medical device industry in a similar role and be adept at using statistical tools. 

Main Duties:
- Participate in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associated company policies and GMP/ISO requirements. 
- Facilitate supplier improvement/corrective action (CAPA)
- Develop and implement systems and processes for supplier/contract manufacturer management that are in compliance with corporate policies, FDA’s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS, CMDR, ISO 13485, MDD/EN46001 and other quality requirements, regulations and guidelines. 
- Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements. 
- Support sustaining engineering projects that may involve manufacturing transfers, label/IFU updates, sub-supplier qualification and design qualification. 
- Lead quality process improvements and streamlining activities. 

- Bachelor's degree in Engineering or Science (Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Physics, Mathematics, etc.)
- 2+ years experience in Quality within the medical device industry
- Use and understanding of Statistical Tools 
- Manufacturing Experience: including assembly, machining and molding (dip/injection) 

Ideal Qualifications:
- Quality System Lead Auditor experience (ISO 13485) 
- Project Management experience 
- Master's degree in Engineering or Science
- Adept at implementing processes 

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