Senior Quality Engineer - (Microbiologist & Sterilization)

BD (Tissuemed Ltd); Kulim; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading medical technology company in Kulim, Malaysia is seeking a professional for Lab management, focusing on microbiology, sterilization, and calibration. This role involves overseeing laboratory activities, developing analytical methods, and ensuring compliance with testing procedures. Candidates should have strong leadership skills and a commitment to quality engineering practices.

Responsibilities

• Oversee laboratory activities including microbiology, sterilization, and calibration.
• Develop new analytical methods and improve test procedures.
• Ensure testing is conducted per written procedures and documented.

Job description

Job Description Summary

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

Job Description

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

• 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.

Required Skills

Optional Skills

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

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