Twist Bioscience - Supplier Quality Engineer – Plastics, China

• 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.