Supplier Quality Engineer – Plastics, China

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.