Supplier Quality Engineer – Plastics, China

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.

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