Supplier Quality Engineer

Supplier Quality Engineer I

6 Months Contract - High possibilities of extension

Englewood, CO

Duties

• Responsible for executing Supplier Production Process Approval (SPPA) remediation activities in support of Quality Management System integration.
• Gathers, reviews, and analyzes supplier manufacturing, quality, inspection, and process data to identify gaps and establish appropriate quality controls.
• Plans and executes assigned supplier remediation activities against established project timelines and works cross-functionally with Supplier Quality, Manufacturing, Development, Quality, and external suppliers to drive activities through completion.

Skills

• Strong knowledge of supplier quality, process validation, process capability, measurement system analysis, and inspection controls.
• Experience evaluating manufacturing processes and quality data, including process capability studies and Gage R&R.
• Ability to interpret engineering drawings, specifications, tolerances, CTQs, and GD&T and translate technical requirements into appropriate process and inspection controls.
• Working knowledge of applicable ISO and QSR/QMSR requirements.
• Demonstrated ability to identify quality and documentation gaps, develop appropriate solutions, and drive remediation activities through closure.
• Strong analytical, problem-solving, communication, and project execution skills, with the ability to work independently and effectively with cross-functional teams and external suppliers.

Education

• Bachelor’s degree in Engineering or an alternative Bachelor’s degree with relevant Quality Engineering experience or certification (e.g., CQE).
• Certification as a Quality Engineer (CQE), Reliability Engineer (CRE), or other applicable ASQ certification preferred.
• Minimum of 2 years of experience in a Quality Engineering, Supplier Quality, or related role, with medical device experience strongly preferred.
• An equivalent combination of education, certification, and relevant experience may be considered.