Job Title: Supplier Quality Engineer ILocation: Englewood, Co, 80112
Duration: 6+ Months
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.
