Lab Operation Support Engineer- Senior Lab Operation Support Engineer

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

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

To support the QA/RA Head of Department in the establishment, operation, and maintenance of the MY site laboratory.

The role is responsible for executing and coordinating laboratory testing activities, managing laboratory equipment and processes, and supporting technical evaluations across different stages of the product lifecycle. The position focuses on laboratory operation and test execution, aligned with corporate technical requirements, without ownership of product development, quality release, or validation decisions.

Qualifications & Experience:

• Minimum Bachelor Degree in Engineering or technical with hands-on experience managing day-to-day lab test equipment, calibration, maintenance, and validation.
• Minimum 2 years of relevant experience in a quality lab, preferably in a medical device, pharmaceutical, or biotech manufacturing environment.
• Knowledge of Health, Safety & Environmental (HSE) Compliance, good laboratory practices (GLP), ISO 13485, FDA 21 CFR Part 820, and GMP standards is added advantages.
• Poses good technical knowledge in handling / maintaining / troubleshooting laboratory instruments and interpreting technical data.
• Experience in introducing and developing the integration of new technology into lab processes to increase productivity, cost effectiveness, quality of work and enhance the capability of the team is an advantage
• Familiarity with machine measurement systems, such as vision cameras and sensors, as well as function testing for leaks and blockages and problem-solving skills are beneficial.
• Experience in project management, failure analysis, and Measurement System Analysis (MSA) are preferred.

Key Responsibilities:

• Support the setup, operation, and continuous improvement of site laboratory facilities, equipment, and workflows.
• Coordinate installation, commissioning, routine maintenance, calibration coordination, and troubleshooting of laboratory instruments to ensure readiness and minimise downtime.
• Maintain laboratory equipment records, status logs, and maintenance documentation.
• Execute laboratory tests in accordance with approved methods, work instructions, and protocols.
• Compile laboratory test data into clear and accurate reports for internal technical evaluation purposes.
• Support technical testing requests related to development, investigation, validation, or post‑market activities, as defined by approved protocols.
• Support the development, adaptation, and documentation of site‑level laboratory test methods where no existing corporate method is available or where site‑specific execution is required.
• Ensure locally developed methods are technically justified, documented, and aligned with applicable corporate technical requirements.
• Support method verification or qualification activities for site‑developed methods, where required.
• Ensure site‑developed methods do not replace or modify product‑defining or specification‑setting test methods without appropriate corporate alignment.
• Develop and maintain laboratory SOPs, work instructions, and operational documentation relevant to laboratory activities.
• Ensure proper control, filing, and traceability of laboratory records, including test reports, equipment logs, and technical data, in accordance with internal procedures.
• Liaise with Corporate Technical & Development teams to align on test methods, technical expectations, and data interpretation, in the absence of a local T&D function.
• Coordinate with external laboratories where specialised or outsourced testing is required.
• Ensure laboratory activities are conducted in alignment with internal procedures and applicable regulatory principles (e.g. ISO 13485, FDA QSR), without implying formal laboratory accreditation (e.g. ISO/IEC 17025).
• Support laboratory‑related investigations by providing test data and technical input, as requested by the relevant function.
• Assist in stability studies and environmental monitoring, as required.
• Prepare and review environmental monitoring trend analysis report.
• Provide technical training and guidance on laboratory equipment, test methods, and procedures to laboratory personnel or new recruits, where applicable.
• Maintain awareness of assigned training requirements and ensure timely completion.
• Manage procurement and inventory of laboratory consumables, reagents, and related supplies.
• Provide backup support for laboratory activities and other assigned technical tasks, as required.
• Support any other duties within the role or task assigned from time to time.
• Be part of a growing medical device company with a new facility launching in the next year
• Excellent career advancement opportunities for high achievers
• Competitive salary package with medical and insurance coverage