Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

Location: Draper, UT (Onsite)

Contract: 6 Months

Pay Rate: Up to $52.50 per hour

Our client is seeking an experienced Senior Supplier Quality Engineer to lead supplier qualification and quality engineering activities supporting new product development and commercial launch programmes.

This highly collaborative position partners with Engineering, R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection to ensure suppliers consistently meet quality, regulatory, and manufacturing requirements.

Responsibilities

• Lead supplier qualification activities supporting new product development and commercial launch timelines.
• Perform gage repeatability and reproducibility (Gage R&R) studies, process capability studies, and supplier process validations.
• Develop, validate, and improve inspection methods and testing processes for critical components.
• Create inspection routines for optical measurement equipment.
• Design and develop inspection fixtures using SolidWorks.
• Provide engineering support to Receiving Inspection teams regarding inspection methods and component investigations.
• Manage supplier-related non-conformances from investigation through resolution.
• Lead Supplier Corrective Action Requests (SCARs) from initiation through successful closure.
• Present supplier qualification status during recurring cross-functional project meetings.
• Collect, analyse, and report supplier quality metrics.
• Communicate supplier quality risks and mitigation plans to project teams and senior management.
• Partner closely with suppliers and internal engineering teams to drive quality improvements throughout the product lifecycle.

Required Qualifications

• Bachelor's degree in Engineering or a related Scientific discipline.
• Minimum four years of engineering experience within a highly regulated industry such as Medical Devices, Aerospace, or Automotive.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 9001, and other applicable quality standards.
• Experience with Design Controls and test method development and validation.
• Experience developing and validating component test methods and inspection equipment.
• Knowledge of statistical quality tools including Gage R&R, Statistical Process Control (SPC), and Process Capability Studies.
• Experience conducting root cause investigations and driving effective corrective and preventive actions (CAPA).
• Ability to read and interpret engineering drawings, including GD&T.
• Understanding of process validation methodologies including IQ, OQ, and PQ.
• Working knowledge of manufacturing processes such as injection moulding, extrusion, machining, or similar.
• Strong analytical, organisational, and problem-solving skills.
• Excellent communication skills with the ability to build relationships across cross-functional teams and external suppliers.

Preferred Experience

• Medical device manufacturing experience.
• Supplier Quality Engineering within regulated manufacturing environments.
• Optical measurement systems.
• SolidWorks for fixture design.
• New product introduction (NPI) and commercial product launches.
• Cross-functional project leadership.

Ideal Candidate

The successful candidate will be proactive, detail-oriented, and comfortable working in a fast-paced engineering environment where supplier quality plays a critical role in successful product development. You'll enjoy collaborating with multiple engineering disciplines, solving complex quality challenges, and driving continuous improvement across the supplier network.

This is an excellent opportunity to contribute to innovative medical device development while working alongside experienced engineering professionals on high-impact projects.

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