Responsibilities Provide quality support to production lines and catheter assembly processes Ensure compliance with GMP, GDP, and ISO 13485 requirements Investigate NCRs, process deviations, and manufacturing failures Lead root cause analysis activities using 8D, 5 Why’s, Fishbone, and CAPA methodologies Monitor quality KPIs, scrap trends, and rework performance Support process validations, engineering changes, and continuous improvement initiatives Participate in internal, corporate, and regulatory audits Collaborate with Manufacturing, Process Engineering, Validation, and Quality teams Qualifications Bachelor’s degree in Engineering or related field 2–3 years of experience as a Quality Engineer within the medical device industry Experience in catheter manufacturing or medical device assembly operations Knowledge of ISO 13485, FDA 21 CFR Part 820, and document control systems Hands-on experience supporting high-volume production floor operations Intermediate to advanced English level #J-18808-Ljbffr
Quality Systems Engineer
FOXCONN BAJA CALIFORNIA, S.A. DE C.V.
tijuana, tijuana
Publicado hace 13 días
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