Senior Quality Engineer - (Microbiologist & Sterilization)

Senior Quality Engineer - (Microbiologist & Sterilization)

BD (Tissuemed Ltd) is seeking a Senior Quality Engineer with expertise in microbiology, sterilization, calibration, and quality engineering activities.

Job Description Summary

Responsible for laboratory management, microbiology, sterilization, calibration, and associated quality engineering activities.

Responsibilities

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

Required Skills

Primary Work Location : MYS Kedah - Bard Kulim (Malaysia)

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

Seniority level Mid-Senior level

Employment type Full-time

Job function Quality Assurance

Industries Medical Equipment Manufacturing

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