Sr. Supplier Quality Engineer (Inspection)

Job Title: Sr. Supplier Quality Engineer (Inspection)

Pay Rate: $50 to $58.27/Hr

Duration: 6 Months

Location: Draper, UT

Our Client is a Global medical device Manufacturer.

We are looking for a Sr. Supplier Quality Engineer with a strong background in incoming mechanical parts inspection, supplier quality, and precision measurement. The ideal candidate will have hands-on experience using vision inspection systems such as Keyence (or equivalent), as well as traditional metrology equipment including gauges, calipers, micrometers, and other inspection tools. This role is responsible for ensuring incoming components meet engineering specifications and quality standards before release to production. leading. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection. The primary focus of the position is leading successful parts qualification efforts with external suppliers to support product development and commercial launch timelines. The Sr. Supplier Quality Engineer will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

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  Lead/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs
• .Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creating inspection fixtures using SolidWorks
• .Provide engineering support to Receiving Inspection on component test methods and investigations
• .Manage supplier-related non-conformances
• .Manage supplier corrective action requests (SCAR) from initiation to closure
• .Report on supplier part qualification status at recurring cross-functional project meetings
• .Collect and analyze Quality metrics relating to Supplier Quality
• .Communicate supplier quality risks to upper management during Management Review and project meetings and identify solutions to mitigate risks

.Skills

• :Bachelor’s degree in Engineering (preferred) or a scientific fiel
• dAt least 4 years of engineering experience in a highly regulated industry (e.g., Medical Device, Aerospace, and Automotive
• )Demonstrated experience in driving component qualification, test method development/validations, and testing/validating equipment
• .Experience with vision inspection systems such as Keyenc
• eExperience with root cause analysis and corrective action methodologies
• .Knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards
• .Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies
• .Ability to conduct effective root cause analysis, drive non-conformance investigations, and assess corrective action strategies and effectiveness as applied through CAPAs
• .Knowledge of GD&T and ability to read and interpret drawings
• .Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.)
• .Good interpersonal skills, with the ability to negotiate and influence change
• .Possess the ability to multitask while maintaining close attention to detail
• .Ability to achieve results in a cross-functional team environment and build strong relationships with internal and external customers (suppliers)