Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

Location: Draper, UT (Relocation is not available; candidates must be local.)

Contract Duration: 6 months (potential to extend)

Pay Range: $50–51/hr.

OPT and visa sponsorship are not available for this role.

The Senior Supplier Quality Engineer will play a key role in supporting critical product development and commercialization projects. This cross-functional role requires close collaboration with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection teams.

The primary responsibility is to lead supplier parts qualification activities to ensure alignment with product development timelines and commercial launch goals. This position operates in a fast-paced, on-site environment where initiative and proactive problem-solving are essential.

• Lead and perform gage studies, process capability studies, and supplier process validations for critical components based on FMEA risk assessments
• Develop and validate test methods, including inspection routines using optical measurement equipment and design of inspection fixtures using Solid Works
• Support Receiving Inspection with component test methods and investigation activities
• Manage supplier non-conformances and drive resolution
• Oversee Supplier Corrective Action Requests (SCARs) from initiation through closure
• Report supplier part qualification status in cross-functional project meetings
• Collect, analyze, and report supplier quality metrics
• Communicate supplier quality risks to management and propose mitigation strategies during management reviews and project meetings

• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, and other applicable international regulatory standards
• Experience with Design Controls and test method development/validation
• Proven experience in component testing, test method validation, and equipment validation
• Strong understanding of statistical tools and methods (Gage R&R, SPC, process capability studies)
• Experience conducting root cause analysis and managing CAPA processes
• Knowledge of GD&T and ability to interpret engineering drawings
• Understanding of process validations (IQ, OQ, PQ)
• Familiarity with manufacturing processes (e.g., injection molding, extrusion, machining)
• Strong interpersonal skills with ability to influence and negotiate
• Ability to manage multiple priorities with strong attention to detail
• Effective collaboration in cross-functional and supplier-facing environments

• Bachelor’s degree in Engineering or a related scientific field
• Minimum 4 years of engineering experience in a highly regulated industry (e.g., medical device, aerospace, automotive)