Quality Assurance Deputy Director – Outsourced Injection Molding

【Client Description】

A U.S.-based medical device company with operations in Taiwan, utilizing extensive outsourced injection-molding and precision manufacturing partners. The organization places strong emphasis on supplier performance, production consistency, and high-quality component reliability.

【Candidate Profile】

• 10+ years of experience in quality assurance, supplier quality management, or injection-molding quality control.

• Strong understanding of injection-molding processes, material variation, mold maintenance, and mass-production stability.

• Proven experience managing outsourced manufacturers, including audits, process validation, and continuous improvement.

• Proficient in quality tools such as 8D, RCA, FMEA, SPC, and sampling plans, with the ability to handle complex quality incidents.

• Capable of preparing and reviewing quality documents, inspection standards, performance metrics, and supplier scorecards.

• Strong communication skills and the ability to work effectively with suppliers, cross-functional teams, and U.S. counterparts.

• Leadership experience at the manager or deputy director level, with the ability to build systems and drive quality improvements.

• Experience in medical devices, precision molding, electronics, or international manufacturing supply chains is preferred.

【Responsibilities】

• Oversee all quality assurance and inspection activities for outsourced injection-molded components, ensuring consistent product quality and supplier performance.

• Establish quality standards, inspection procedures, and supplier management frameworks for contract manufacturing vendors.

• Lead supplier audits, on-site process reviews, mold condition assessments, and performance evaluations for injection-molding partners.

• Supervise incoming inspection, in-process checks, final inspection, and shipment release for outsourced components.

• Drive root cause investigation and corrective actions for quality issues, coordinating closely with suppliers and internal stakeholders.

• Develop and maintain inspection criteria, sampling plans, testing instructions, and related quality documents for injection-molded parts.

• Support new product introduction, mold qualification, pilot runs, and quality approval processes during ramp-up.

• Provide regular quality performance reports, supplier risk assessments, and corrective action updates to the U.S. headquarters.

• Lead and mentor the QA/QC team, including manpower planning, skill development, workflow optimization, and performance management.