Technician - Quality (13909)

B. Braun Medical Industries Sdn. Bhd.; Penang; On-site; MYR 42,000 - 68,000; Full time

Job summary

B. Braun Medical Industries Sdn Bhd in Penang is seeking aCalibration Technician to execute preventive maintenance and calibrate all OAQ IMTE across two campuses and three buildings.

You will coordinate calibration activities with internal and external service providers while ensuring GMP compliance and adherence to calibration master schedules. The role requires a Diploma with basic working experience and 1–2 years in the medical industry, plus knowledge of ISO 13485 and FDA 21 CFR Part 820.

Qualifications

• Diploma with basic working experience.
• At least 1-2 years of working experience in the medical industry.
• Knowledge of ISO 13485.
• FDA 21 CFR Part 820.

Responsibilities

• Executes preventive maintenance and calibrates all OAQ IMTE across 2 Campus/3 Buildings (B12, B9 & B3), comprising 10 OAQ Labs.
• Assists calibration service provider on sites and performs initial equipment buyoff if calibration meets requirements.
• Documents calibration reports and updates calibration history cards for GMP & quality compliance.

Skills

Calibration

Preventive maintenance

GMP awareness

Education

Diploma with basic working experience

Job description

Key Functions: Execute preventive maintenance and calibrate all OAQ IMTE across 2 Campus/3 Buildings (B12, B9 & B3), consisting of 10 OAQ Labs [CPCS, Molding, IVC, Needle & EIS]

Task Descriptions:

Ensures equipment are calibrated according to the master schedules and meet registered industry/manufacturing standards.

Assist calibration service provider (Internal / External) on sites for equipment calibration and perform initial equipment buyoff if the calibration meets the requirements. Else, this shall be further communicated with Engineer for next course of actions.

Document calibration report and update calibration history card for GMP & quality compliance as this quality record shall be subjected for compliance audits.

Coordinate with IMTE Users (stakeholders) by referencing to Preventive Maintenance Master List in monthly basis for calibration activities to avoid/minimize its impacts in routine QC operations.

Internal PM: Perform internal maintenances and update the PM checklist.

External PM: Assist and ensure the external service provider shall complete the PM according to our schedule and checklist while adhering to BMI GMP protocols when carrying out job in clean room.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time

REQUIREMENTS:

Diploma with basic working experience.

At least 1-2 years of working experience in the medical industry.

Knowledge of ISO 13485.

FDA 21 CFR Part 820.

B. Braun Medical Industries Sdn Bhd (BMI) is a subsidiary of B. Braun Melsungen AG, Germany, one of the largest medical devices companies in the world. Established in 1972, B. Braun Medical Industries in Penang is the group’s first manufacturing site in Asia Pacific Region and it is one of the largest B. Braun manufacturing sites for the group outside Europe.

Since its inception in 1972, B. Braun Medical Industries has invested more than MYR4.3 billion in its manufacturing facilities in Malaysia. With more than 7,500 employees, the plant located in Penang is among the largest manufacturers of Medical and Pharmaceutical products not only in Malaysia but also in the region.

Are you looking for a challenge within a dynamic global organisation or a German family business? At B. Braun you can find both. For more than 180 years and counting, B. Braun is amongst the world's top healthcare companies operating in 64 countries, with over 60,000 experts networking their knowledge every day. You can thrive in this strong culture of continuous exchange. Become a part of the B. Braun family and share your expertise. Together we improve healthcare.