Supplier Quality Engineer

Summary

This is an opportunity to join a fast-growing and well-funded medical technology innovator that is building non-invasive diagnostic and therapeutic devices using proprietary optical imaging and ultrasound technologies. With offices in the U.S. and Asia, the company combines consumer electronics speed with medical-grade precision, working with global research hospitals and clinical
partners.
Their products are on track to enter clinical and commercial deployment, and they are now expanding their supply chain and quality teams in Asia.

Role Overview

As the Supplier Quality Engineer, you will play a critical role in ensuring the quality of both contract manufacturers and component suppliers. You will oversee supplier performance, audit compliance with international medical device regulations, and manage product lifecycle quality documentation through Arena PLM. This role supports both new product introductions (NPI) and
sustaining engineering, working closely with internal R&D, manufacturing, and external supplier teams across regions.

Responsibilities

Supplier Quality Management

• Establish and maintain supplier quality systems aligned with ISO 13485,FDA QSR, ISO 9001, etc.
• Evaluate and qualify new suppliers (FAI, PPAP, IQ/OQ/PQ); conductregular audits and performance reviews
• Lead issue investigation and corrective action (CAPA, SCAR, root causeanalysis, non-conformance tracking)
• Track supplier performance using key metrics (PPM, SCARs, scorecards,etc.)
• Manage inspection and quality control of incoming materials to ensurecompliance with specifications
• Provide supplier training, guidance, and continuous improvement feedback
• Support supplier-related documentation including specs, FMEA, inspection standards, and control plans
•  Collaborate with internal cross-functional teams on quality targets, ECOrouting, and risk mitigation

PLM and Documentation (Arena PLM)

• Administer and maintain Arena PLM system for product lifecycle anddocument control
• Manage controlled document workflows: creation, review, approval, andrevision
• Ensure traceability and version integrity for BOM, AVL, technical files, and ECOs
• Coordinate cross-team documentation input and maintain audit readiness
• Conduct internal audits for PLM/documentation compliance; generatereports and metrics

Requirements

• BS in Engineering, Quality Assurance, or related technical field
• 8+ years of quality engineering experience, with at least 5 years in medical device manufacturing
• Familiar with ISO 13485, ISO 9001, FDA QSR, and related standards
• Strong knowledge of SPC, FMEA, CAPA, and supplier audit methodologies
• Hands-on experience managing contract manufacturers and component suppliers
•  Experience with Arena PLM or similar systems is required
• Fluent in Mandarin and English; comfortable communicating with global
  teams
• Willing to travel domestically and internationally for supplier visits and
  audits

Post Time｜2025/06/17