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Supplier Quality Engineer

South Bend, Indiana
This role is within a leading medical diagnostic company, that offers cutting edge technology, machines, and rapid testing solutions at physicians’ fingertips. This is a newly created opening to support new growth as well as existing areas of business (30+ year history).
Supplier Quality Engineers in this facility are primarily responsible for all quality related aspects of raw material entering the plant. This includes day to day support of the manufacturing line, problems that occur, and non-conformance that may be generated.

Job Description

Senior Supplier Quality Engineer
South Bend, IN (Relocation Assistance Provided)
<2 hours Chicago, <1 hour from the Lake Michigan Beach!
Competitive Base Salary, Bonus, 6% 401K Match, Full Benefits, 4 weeks PTO
 
Duties and Responsibilities:
  • Support design transfer of new production coming into the facility, including raw material specification development, supplier audits and supplier monitoring/qualification, and development of incoming inspection processes
  • Interact with multiple functions across sites including Engineering, Manufacturing, Technical Operations, and Regulatory Compliance
  • Become Subject Matter Experts on all aspects of each raw material
  • Lead the MRB process to resolve material non-conformances
  • Write or revise necessary production-controlled documents as needed
  • Participate as a manufacturing Subject Matter Expert on any process change to assure that proper documentation, validations, and/or qualifications are performed
  • Responsible for assuring prompt completion of process related quality notifications and tracking/reporting all necessary tasks to assure completion. Serve as Quality Notification coordinator
  • Participate in root cause investigations.
  • Participate in CAPA Review Board as required
  • Participate in Validation Review Board as required
  • Prepare for FDA inspections and registrar audits
  • Able to effectively communicate with internal and external customers

Qualifications

Qualifications:
Desired Bachelors Science – Industrial Engineering
5-10+ years of Supplier Quality Experience; ideally with immunoassay experience with microfluidics, protein chemistry, and ELISA
Process Control Technology experience desired
Statistical knowledge and Design of Experiments experience
Strong procedure development/technical writing skills
Value Stream Mapping/Lean experience is helpful
Strong communications background, both written and verbal
ASQC Certifications helpful
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