Sr Engineer

Ultimate Staffing Services; Draper (UT); On-site; USD 83,000 - 92,000; Full time

Job summary

Ultimate Staffing Services is seeking a Senior Supplier Quality Engineer to lead parts qualification with external suppliers, collaborating with R&D, Design Assurance, Operations, Regulatory Affairs, and more. The role includes coordinating with cross-functional teams and driving proactive quality initiatives on a fast-paced, on-site environment in Draper, UT.

The position emphasizes gage studies, process validation, and SCAR management to support product development and launches.

Qualifications

• Bachelor’s degree in Engineering or a scientific field and at least 4 years in a highly regulated industry.
• Knowledge of FDA 21 CFR Part 820, ISO13485, ISO9001 and related standards.
• Experience leading qualification activities and CAPA-driven improvements.

Responsibilities

• Lead/gage studies, process capability studies, and supplier validations for critical features.
• Develop and validate inspection methods and fixtures (SolidWorks).
• Support Receiving Inspection test methods and investigations.
• Manage SCARs from initiation to closure.
• Report supplier qualification status at cross-functional meetings.
• Analyze quality metrics for Supplier Quality and escalate risks.
• Communicate supplier risks to management and drive corrective actions.

Skills

21 CFR 820

ISO 13485

ISO 9001

Design Controls

Gage R&R

SPC

CAPA

GD&T

IQ/OQ/PQ

Manufacturing processes

Education

Bachelor’s degree in Engineering or Scientific field

Job description

Salary: USD60 - USD66.6 per hour

Location – Draper, UT 84020

Duration – 6 Months - chance of an extension

Max Pay – $60.00-$66.60/HOUR W2

Summary:

The Senior Supplier Quality Engineer will play a key role on critical projects. 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.

Job Responsibilities:

• 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 creation of inspection fixtures using SolidWorks.
• Provide engineering support to Receiving Inspection on component test methods and investigations.
• 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:

• Knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards.
• Experience and/or proficient knowledge of Design Controls and test method development/validations.
• Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
• 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; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs.
• Knowledge of GD&T and ability to read and interpret drawings.
• Good understanding of process validations (IQ, OQ, PQ)
• 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 multi-task, while maintaining high attention to detail.
• Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers (suppliers).

Education/Experience:

• Bachelor’s degree in Engineering or Scientific field
• At least 4 years of engineering experience in highly regulated industry (e.g. Medical Device, Aerospace, and Automotive)