Quality Technician (Night Shift)

Quality Technician (Night shift)

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Quality Technician is responsible for executing quality operations related activities, including testing at In-coming, In-processes and Out-going to ensure that products comply with quality standards, per BIOTRONIK specifications under cGMP and Quality System rules. The Quality Technician, who is stationed in a Clean Room environment, also assists the Quality Engineers in collecting and analyzing the quality data and ensuring quality standard compliance in the production floor.

Your Responsibilities

• Timely disposition of Non-conformities, including the blocking of products for further investigation.
• Execution of standardized root-cause analysis.
• Error gathering, cataloging and monitoring of defect trending.
• Labeling, inventory, and bookings of data and defective product storage locations in accordance with the QM specifications.
• Coordination of analytical tests and assist the engineers in evaluation of results.
• Coordination of deviations in consultation with Quality Engineers.
• Training and certification of production personnel on inspection specifications in accordance with inspection specifications.
• Collaborate with Production team in implementing the QM specifications.
• Subject matter expert in the production line for all quality-related enquiries and provide Quality related advice in the production line.
• Continuous monitoring and planned verification of issues, processes, etc. on QM specifications compliance, in the corresponding production area.
• Identification of opportunities for improvement and to perform line auditing.
• Supporting incoming inspection activities including the coordination of any deviations in consultation with Quality engineers.
• Support, execute projects and any others activities as directed by engineers or supervisor.

Your Profile

• At least GCE "O" Level, ITE/NITEC in the field of Mechanical, Electrical, Bioengineering discipline, relevant Quality Certification or equivalent.
• At least 1 year of experience in quality technician role in a regulated environment OR manufacturing environment (eg: medical devices, pharmaceutical) will be an advantage.
• Microsoft Outlook, Word, Excel, Powerpoint, Sharepoints, Teams
• Quality Inspections techniques and experiences in handling measuring instruments.

• Experience in incoming inspections tools i.e vision measuring system preferred

• Basic Quality Analytical Tools.

• Experience with SAP and MES preferred (Manufacturing Execution Systems).
• Comprehending Technical Drawings.
• Cleaning and Hygiene Regulations.

What we offer

• being encouraged to think and act entrepreneurially.
• working in global teams and projects.
• developing yourself professionally.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Singapore | Working hours: Full-Time

Job ID: 60975

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.