Remote Senior Mfg & Quality Engineer – Medical Devices

PT Talenta Eksekutif Asia; George Town; Remote; MYR 180,000 - 240,000; Full time

Job summary

PT Talenta Eksekutif Asia seeks a Senior Manufacturing & Quality Engineer for Medical Devices & Consumer Electronics in Malaysia. You will lead manufacturing processes, QA systems, and production readiness for hardware, collaborating with contract manufacturers and suppliers across the product lifecycle.

The role requires 9+ years in manufacturing or quality engineering, with hands-on experience in injection molding, SMT, and medical device quality, plus ISO 13485/FDA knowledge.

Qualifications

• Bachelor's or Master's degree in a relevant engineering discipline.
• 9+ years of professional experience in manufacturing process support, manufacturing engineering, or quality engineering.
• Experience taking hardware products from development through NPI to mass production in high-volume environments.
• Experience in consumer electronics and/or electro-mechanical medical devices.
• Knowledge of injection molding, SMT, testing, and packaging processes.

Responsibilities

• Lead development, validation, and maintenance of manufacturing processes, fixtures, tooling, and production systems.
• Drive NPI programs from early development through EVT, DVT, PVT, to mass production.
• Ensure suppliers and contract manufacturers meet design, fabrication, assembly, testing, and quality requirements.
• Lead quality processes across manufacturing and supplier operations.
• Apply pFMEA, CAPA, and structured problem solving to resolve issues.
• Collaborate with CM, JDM, ODM, and OEM partners and align quality expectations.
• Travel regionally to support suppliers and production sites.

Skills

Manufacturing Engineering

Quality Engineering

Electronics manufacturing

Cross-functional collaboration

Problem solving

English, Mandarin, Malay fluency

Education

Bachelor's or Master's Degree in Manufacturing/Mechanical/Electrical Engineering or related

Job description

PT Talenta Eksekutif Asia seeks a Senior Manufacturing & Quality Engineer for Medical Devices & Consumer Electronics in Malaysia. You will lead manufacturing processes, QA systems, and production readiness for hardware, collaborating with contract manufacturers and suppliers across the product lifecycle.

The role requires 9+ years in manufacturing or quality engineering, with hands-on experience in injection molding, SMT, and medical device quality, plus ISO 13485/FDA knowledge.