Lab Operations Engineer — Medical Device Testing & Compliance

Intersurgical Medical Sdn Bhd; Seberang Perai; On-site; MYR 67,000 - 100,000; Full time

Benefits offered by this job

Medical coverage

Career advancement opportunities

Job summary

Intersurgical Medical Sdn Bhd in Malaysia is seeking a QA/RA site lab support role to assist in establishing and maintaining the MY site laboratory. The role focuses on executing tests, maintaining instruments, and supporting technical evaluations across the product lifecycle, without ownership of product development or release decisions.

The candidate should have at least a bachelor degree in engineering or technical field, 2 years of lab experience, and familiarity with HSE, GLP, ISO 13485,

Qualifications

• Bachelor degree in Engineering or technical field.
• 2 years of QA lab experience in medical device/pharma environments.
• Knowledge of HSE, GLP, ISO 13485, FDA 21 CFR Part 820, GMP.
• Ability to handle, maintain and troubleshoot lab instruments and interpret data.
• Experience integrating new technology into lab processes to improve productivity and quality.
• Familiarity with measurement systems and function testing to support reliability.

Responsibilities

• Support setup, operation, and continuous improvement of site laboratory facilities, equipment, and workflows.
• Coordinate installation, commissioning, maintenance, calibration, and troubleshooting of instruments to minimize downtime.
• Maintain laboratory equipment records and maintenance docs.
• Execute tests per approved methods, work instructions, and protocols.
• Compile test data into clear reports for internal evaluation purposes.
• Support testing requests related to development, investigation, validation or post‑market activities.
• Develop and document site‑level lab test methods where needed, ensuring alignment with corporate requirements.
• Ensure site methods do not replace critical product testing without corporate approval.
• Develop and maintain laboratory SOPs and operational docs.
• Ensure proper filing and traceability of lab records per internal procedures.
• Liaise with Corporate Technical & Development teams to align on test methods and data interpretation.
• Coordinate with external labs for specialized testing.
• Ensure activities align with regulatory principles (ISO13485, FDA QSR) without implying ISO/IEC 17025 accreditation.
• Support investigations with test data and technical input.
• Assist in stability studies and environmental monitoring as required.
• Provide training and guidance on lab equipment and procedures.
• Manage procurement and inventory of consumables and reagents.
• Provide backup support for lab activities and other tasks.
• Be part of a growing medical device company with a new facility and career advancement opportunities.

Skills

Bachelor degree

Lab testing

Calibration

Troubleshooting

Project management

MSA

Education

Bachelor degree in Engineering or technical

Tools

Lab instruments

MSA

Calibration equipment

Job description

Intersurgical Medical Sdn Bhd in Malaysia is seeking a QA/RA site lab support role to assist in establishing and maintaining the MY site laboratory. The role focuses on executing tests, maintaining instruments, and supporting technical evaluations across the product lifecycle, without ownership of product development or release decisions.

The candidate should have at least a bachelor degree in engineering or technical field, 2 years of lab experience, and familiarity with HSE, GLP, ISO 13485,