Medical Device Validation Engineer (IQ/OQ/PQ)

Bright Prospect; Bayan Lepas; On-site; MYR 45,000 - 65,000; Full time

Job summary

A leading medical device company in Bayan Lepas, Penang, is seeking a Validation Engineer. This role involves ensuring compliance with validation protocols and quality standards, developing Master Validation Plans, and collaborating with multidisciplinary teams. The ideal candidate will hold a Bachelor’s degree in Engineering and have at least 1 year of experience in a regulated environment. Strong knowledge of FDA and ISO requirements is essential for success in this dynamic role.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Science, Biomedical, or related field).
• At least 1 year of experience in validation within a regulated industry (medical devices preferred).
• Strong understanding of IQ/OQ/PQ and validation lifecycle.

Responsibilities

• Ensure validation protocols comply with quality standards and regulations.
• Develop and maintain Master Validation Plans.
• Collaborate with cross-functional teams to execute product qualifications.

Skills

Validation protocols

Quality assurance

Technical writing

Statistical analysis

Education

Bachelor’s degree in Engineering

Tools

FMEA

PFMEA

Job description

A leading medical device company in Bayan Lepas, Penang, is seeking a Validation Engineer. This role involves ensuring compliance with validation protocols and quality standards, developing Master Validation Plans, and collaborating with multidisciplinary teams. The ideal candidate will hold a Bachelor’s degree in Engineering and have at least 1 year of experience in a regulated environment. Strong knowledge of FDA and ISO requirements is essential for success in this dynamic role.