Senior Quality Engineer - (Microbiologist & Sterilization)

BD Malaysia; Kulim; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading healthcare solutions provider is seeking a Senior Quality Engineer based in Kulim, Kedah, Malaysia. The role involves overseeing laboratory activities, ensuring quality compliance, and managing a team of technicians. Ideal candidates will have a strong background in microbiology and sterilization processes, and will be responsible for training and maintaining high standards in the laboratory. Competitive salary and conditions apply.

Qualifications

• Experience in microbiology lab management required.
• Understanding of sterilization validation processes.
• Able to develop and improve analytical methods.

Responsibilities

• Oversee laboratory activities and manage functions associated with testing.
• Train new Microbiology Lab Technicians and ensure adherence to procedures.
• Perform sterilization validation and manage lab budget.

Skills

Microbiology

Sterilization

Calibration

Quality Engineering

Good Laboratory Practice

Job description

Senior Quality Engineer - (Microbiologist & Sterilization)

Job Description Summary

Responsible for Lab management – Microbiology, Sterilization, Calibration and associated Quality Engineering Activities.

Job Description

• 1. Oversee the laboratory activities inclusive of microbiology lab activities, sterilization, calibration and chemistry lab activities (if necessary). Manage all laboratory functions and activities associated with all testing analysis.
• 2. Explore and develop new analytical methods or improve current test procedures/technologies.
• 3. Responsible for ensuring that all testing performed at the lab is carried out according to written procedures and properly documented.
• 4. Responsible for the maintenance and operations of Microbiology Lab including supplies and equipment.
• 5. Maintain the housekeeping of all Lab.
• 6. Maintain and update, when necessary, all lab procedures and test methods.
• 7. Responsible for the training of new Microbiology Lab Technicians and retraining of the above.
• 8. Report on regular basis all laboratory issues to superior.
• 9. Responsible for performing sterilization validation/revalidation and autoclave validation/revalidation.
• 10. Design investigation program and engineering experiments to determine sources of product nonconformances. Analyze results and recommend action.
• 11. Assist superior in executing special projects or assignments.
• 12. Ensure that all Microbiology Lab Technicians are being trained and that they adhere to instructions in the BOPs.
• 13. Prepare and adhere to annual budget for areas under responsibility.
• 14. Communicate issues relating to Microbiology Lab and Quality issues externally.
• 15. Train Microbiology Lab Technicians on test procedures and “Good Laboratory Practice”.
• 16. QA Representative or Project Leader for associated Design and Non-Design Change Project.
• 17. Perform any other relevant and related responsibilities that may be assigned from time to time as required by the Management.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)