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Quality Engineer - NPI & Sustaining (Medical Devices)

Plasticos Castella SA

How will you make an impact? As a Quality Engineer at our Auburn Hills site, you will support global customer accounts by leading quality assurance efforts across manufacturing operations. Auburn Hills specializes inhigh-mix, low-to-medium volume product solutionswith a focus on thehealthcare, analytical instrumentation, and automotive industries. You will serve as a technical liaison between Jabil, suppliers, and customers, ensuring compliance with regulatory standards and driving continuous improvement. Your success in this role will depend on yourattention to detail, ability tocommunicate effectively, and deep understanding ofmedical manufacturing quality control. Location: On-site at our Auburn Hills, MI facility What will you do? Lead and support manufacturing problem-solving activities to meet customer demands. Serve as an escalation point for interpreting quality standards and resolving disputes. Maintain and review Visual Aids, Control Plans, and Process FMEAs. Manage product disposition through MRB, NCR, and QN processes. Develop and maintain production documentation including purges, quality alerts, deviations, and risk assessments. Participate in Advanced Quality Planning (AQP) and Product Lifecycle Management (PLCM). Develop and execute qualification protocols and summary reports. Conduct capability studies and analyze critical process data. Deliver training to production teams on quality and qualification procedures. Own supplier interactions, audits, and CAPA processes for the site. Support continuous improvement through daily CAC and weekly QIC meetings. Perform defect trend analysis across internal, customer, and supplier data. Conduct routine GEMBA walks and engage with manufacturing teams. Act as liaison for quality issues and engineering change notifications. Participate in PPAP activities for customer, supplier, and internal changes. Provide on-call support and participate in audits as needed. Maintain a clean and safe work environment following 6S principles. Comply with all Environmental Health and Safety standards and work rules. How will you get here? Education: Bachelor’s degree required. Experience: Minimum of 5 years of experience in Manufacturing Engineering or Quality Engineering. Experience inmedical device manufacturingand regulated environments preferred. Knowledge, Skills, Abilities: Strong knowledge of quality theory, CAPA, and validation procedures. Ability to apply statistical methods (e.g., Cpk, Gage R&R, probability theory). Advanced PC skills and familiarity with Jabil’s software systems. Excellent verbal and writtencommunication skills. Ability to present effectively to customers and internal teams. Strong analytical, interpretive, and problem-solving skills. High level ofattention to detailin documentation and process control. Experience with ISO 9001 compliance. Preferred Qualifications: ASQ certifications (CQE, CQA, CQT). Experience with surface mount electronics assembly. #J-18808-Ljbffr Plasticos Castella SA

Vacancy posted 4 days ago
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