Medical Device Validation Engineer

Cochlear Limited; Kuala Lumpur; On-site; MYR 78,120 - 122,760; Full time

Job summary

Cochlear Malaysia is seeking a Validation Engineer to support manufacturing validation activities. You will work with Process Engineering, Manufacturing Engineering, Quality Engineering, Software Validation, and Design to ensure products meet quality and regulatory standards.

Ideal candidates have 3–5 years in V&V, strong knowledge of IQ/OQ/PQ, GDP, and QMS. A regulated manufacturing background in medical devices or semiconductor industries is highly regarded.

Qualifications

• Bachelor's degree in Mechanical, Chemical, Industrial or related engineering.
• 3–5 years in Validation & Verification, Process Validation or similar in regulated manufacturing.
• Experience in medical device/pharmaceutical/semiconductor industries preferred.
• Good understanding of QMS and regulatory standards (ISO 13485, ISO 14971, 21 CFR 820).

Responsibilities

• Plan, execute and review validation activities for processes, equipment, test methods and facilities.
• Support design transfer and new equipment installations into manufacturing.
• Prepare and review validation protocols, plans, reports and IQ/OQ/PQ docs.
• Ensure validation activities comply with QMS and regulatory standards.
• Maintain traceability between design requirements and validation throughout lifecycle.
• Collaborate with cross-functional teams to provide validation guidance.
• Support investigations, NCRs, and CAPAs; assess changes to maintain validated systems.
• Monitor regulatory requirements and seek continuous improvement in validation.
• Build strong relationships with local and global stakeholders.

Skills

V&V

IQ/OQ/PQ

GDP

Risk analysis

Cross-functional collaboration

Regulatory understanding

Education

Engineering degree (Mechanical / Chemical / Industrial)

Tools

GDP

Job description

Cochlear Malaysia is seeking a Validation Engineer to support manufacturing validation activities. You will work with Process Engineering, Manufacturing Engineering, Quality Engineering, Software Validation, and Design to ensure products meet quality and regulatory standards.

Ideal candidates have 3–5 years in V&V, strong knowledge of IQ/OQ/PQ, GDP, and QMS. A regulated manufacturing background in medical devices or semiconductor industries is highly regarded.