Senior Supplier Quality Engineer – Contract (6-month)
Draper, UT | Up to $52.50/hr
We are looking for an experienced Senior Supplier Quality Engineer to join a dynamic, fast-paced medical device team on a 6-month contract basis in Draper, UT. This is a cross-functional role requiring close collaboration with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection. The primary focus is leading successful parts qualification with external suppliers to support product development and commercial launch timelines.
Key Responsibilities:
- Lead and perform gage studies, process capability studies, and supplier process validations for critical component features based on FMEA risk identification
- Develop and validate test methods, including creating inspection routines on optical measurement equipment and designing inspection fixtures using SolidWorks
- Provide engineering support to Receiving Inspection on component test methods and investigations
- Manage supplier-related non-conformances and corrective action requests (SCARs) from initiation to closure
- Report on supplier part qualification status at recurring cross-functional project meetings
- Collect and analyze supplier quality metrics
- Communicate supplier quality risks to upper management during Management Review and project meetings, with mitigation strategies
Required Skills:
- Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, and international regulatory standards
- Experience with Design Controls and test method development/validation
- Proficiency in statistical tools: Gage R&R, SPC, Process Capability Studies
- Strong root cause analysis and CAPA management skills
- Knowledge of GD&T and ability to read engineering drawings
- Understanding of process validations (IQ, OQ, PQ) and manufacturing processes (injection molding, extrusion, machining, etc.)
- Strong interpersonal, negotiation, and cross-functional collaboration skills
Education & Experience:
- Bachelor's degree in Engineering or a Scientific field
- Minimum 4 years of engineering experience in a highly regulated industry (Medical Device, Aerospace, or Automotive)
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