Supplier Quality Engineer – Plastics, China The Supplier Quality Engineer (SQE) – Plastics, China owns the technical quality and process qualification of injection-molded and extruded plastic component suppliers across the China supply base. This role works in close partnership with the Staff Category Manager – Plastics (Technical CBM), China, who owns commercial strategy, cost, and tooling assets, while the SQE owns supplier quality systems, part/process qualification, and day-to-day quality performance — together forming the technical and commercial backbone of the plastics supply chain. What You'll Be Doing - Lead supplier quality qualification for new and existing plastics suppliers, including quality system audits (ISO 9001 / IATF 16949 / ISO 13485 as applicable) and process capability assessments of molding and extrusion lines. - Own PPAP/FAI submission review and approval for molded and extruded components, including dimensional reports, material certifications, and process capability studies (Cpk/Ppk). - Partner with the Technical CBM on supplier selection and tooling readiness by providing an independent quality assessment of candidate molders during RFQ and onboarding. - Drive root-cause analysis and corrective/preventive action (8D, 5-why, fishbone) for plastics quality escapes such as warpage, shrinkage, flash, short-shots, sink marks, and cosmetic/dimensional non-conformances. - Define and maintain incoming inspection plans and sampling strategies for plastic components, including critical-to-quality (CTQ) characteristics and control plans. - Conduct on-site supplier audits and process reviews in China (molding floor, tooling shop, resin handling/drying, cleanroom where applicable) and drive continuous improvement plans. - Support engineering change management (ECN/ECO) by validating that plastics suppliers requalify tooling and processes per change control requirements. - Own supplier quality scorecards (PPM, on-time delivery, CAPA closure rate) and lead quarterly business reviews jointly with the Category Manager. - Support New Product Introduction (NPI) by leading DFM/DFA quality reviews, mold-flow analysis input, and pilot-run/qualification builds. - Manage non-conforming material dispositions (use-as-is, rework, scrap) in coordination with Engineering, Manufacturing, and the Category Manager. - Ensure supplier compliance with material traceability, RoHS/REACH, and other applicable regulatory requirements. - Uphold internal and external policies, regulations, and laws. - Follow regulatory requirements and ISO 13485. What You'll Bring to the Team [Competency/Qualifications] - B.S. in Mechanical/Industrial/Polymer Engineering, Materials Science, Quality Engineering, or related technical field, or equivalent work experience. - 5+ years' experience in supplier quality engineering, with a significant focus on injection-molded or extruded plastic components. - Hands-on knowledge of injection molding and extrusion processes, mold tooling, and engineering thermoplastics/resins (e.g., PC, ABS, POM, PP, PEEK, LCP, TPE). - Practical experience with PPAP/FAI, process capability studies (Cpk/Ppk), GD&T and dimensional inspection (CMM, optical comparators), and control plans. - Certified or experienced quality auditor (ISO 9001 / IATF 16949 / ISO 13485); Six Sigma Green/Black Belt a plus. - Strong root-cause and corrective-action methodology skills (8D, 5-why, fishbone, FMEA). - Fluent Mandarin and English, with the ability to work directly and technically with China-based molders and tooling shops on the shop floor. - Comfortable working cross-functionally with sourcing/category management, R&D, and manufacturing engineering to balance cost, tooling, and quality priorities. - Superb communication skills. - Excellent organizational and time management skills. - Exceptional analytical and problem-solving abilities. - Willingness to travel within China (and occasionally internationally) to audit and support supplier sites. - Able to analyze, prepare, and deliver quality data and presentations to management. Proficient with Microsoft Excel, PowerPoint, and Word. Minitab and SAP/QMS software knowhow preferred. - Experience in the Life Science, Medical Device, or Diagnostics industry, and/or plastics component quality management for regulated products, preferred.

Supplier Quality Engineer – Plastics, China

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