Job Overview
Location
REMOTE- GSO Zhongshan, Guangdong
Job Type
Full-time
Category
QA Engineer
Date Posted
May 15, 2026
Full Job Description
đź“‹ Description
- • Lead sample evaluation, process validation, and performance testing during new product development phases and ensure seamless technology transfer to SQE/QC teams.
- • Perform in-line and finished product verification in compliance with company and international standards to maintain acceptable quality levels across medical device production.
- • Ensure suppliers fully understand and adhere to all company and international standards, processes, and procedures related to medical devices.
- • Conduct process audits to identify opportunities for continuous improvement in process control, production control, and quality control systems.
- • Partner with QA, PM, and Sourcing teams to define appropriate testing parameters that minimize product failures and enhance reliability.
- • Manage vendor-related quality projects including product design changes, quality performance improvements, and ongoing monitoring of critical product quality metrics.
- • Lead root cause investigations for customer complaints, develop and implement CAPAs to reduce recurrence, and verify proper implementation of corrective actions.
- • Collaborate with suppliers and company QC teams in Asia to reduce product rejections and improve overall yield and conformity.
- • Identify and drive supplier-led opportunities for product and process improvements that result in measurable cost savings.
- • Validate and optimize production parameters in collaboration with suppliers, ensuring all changes are fully documented, verified, and maintained in controlled systems.
- • Serve as the primary quality liaison between international suppliers and Medline’s U.S. corporate office to resolve quality-related issues and align global standards.
- • Provide quality engineering input to cross-functional teams to support project completion and ensure compliance throughout the product lifecycle.
- • Apply knowledge of quality management systems (ISO 13485 or ISO 9001) to guide audits, validations, and compliance activities across manufacturing and supply chain operations.
- • Maintain clear documentation and traceability of all quality-related activities, including test results, audit findings, CAPA records, and process validation reports.
- • Communicate effectively across global teams in English to report findings, coordinate actions, and drive quality initiatives with vendors and internal stakeholders.
🎯 Requirements
- • B.S. Degree in Mechanical Engineering, Materials Engineering, Industrial Engineering, or a Medical Device-related engineering field
- • 3+ years of engineering experience with required expertise in process control and quality control
- • Proven experience in process validation and project management within medical device manufacturing
- • Understanding of ISO 13485 or ISO 9001 quality system requirements
- • Excellent English speaking, reading, and writing skills
🏖️ Benefits
- • Health insurance
- • Life and disability insurance
- • 401(k) contributions
- • Paid time off
- • Access to Employee Assistance Program
- • Access to Employee Resource Groups
- • Access to Employee Service Corp
Skills & Technologies
About Medline Industries, LP
Medline manufactures and distributes medical supplies, devices, and clinical solutions to hospitals, surgery centers, extended-care facilities, physician offices, and home-care agencies worldwide. The product portfolio spans infection prevention, patient care, surgical instruments, durable medical equipment, advanced wound care, and diagnostics. Founded in 1966 as a family-owned enterprise, the company operates manufacturing, distribution, and logistics centers across North America, Europe, and Asia, providing supply chain management, clinical programs, and data analytics to improve patient outcomes and operational efficiency.
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