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 and control of non-conforming products, including identification, segregation, and blocking for further investigation.
• Review and manage rework-related quality issues encountered in the production line, including verification of rework results and release or return of products to Production in accordance with approved requirements.
• Handling of unreleased collars for Final Leads processing in accordance with established quality and inspection requirements.
• Execute standardized root-cause analysis and support investigations, corrective actions, and continuous improvement activities.
• Gather, monitor, and analyze quality data, including defect and non-conformity trends, and provide relevant quality reports to stakeholders.
• Ensure proper labeling, inventory, traceability, and storage of defective products and quality-related materials in accordance with QM requirements.
• Coordinate deviations and analytical testing activities in consultation with Quality Engineers and support the evaluation of results.
• Train and certify Production personnel on applicable inspection specifications and quality requirements.
• Collaborate with Production to ensure compliance with QM specifications, inspection requirements, and established quality standards.
• Serve as the quality point of contact for the assigned production area and provide quality guidance and support, particularly during the night shift.
• Perform routine quality monitoring, verification, and line audits to identify quality risks and opportunities for improvement.
• Support incoming inspection activities and other quality-related projects or activities as assigned by the Quality Engineer or Supervisor.
• Ensure proper documentation, escalation, and handover of significant quality issues to ensure effective follow-up and continuity across shifts.

Y****our Profile

• Minimum GCE “O” Level, ITE/NITEC in Mechanical, Electrical, Bioengineering or related discipline, relevant Quality certification, or equivalent qualification.
• Minimum 1 year of experience in a Quality Technician role, preferably in a regulated or manufacturing environment such as medical devices or pharmaceuticals.
• Proficient in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, SharePoint, and Teams.
• Knowledge and experience in quality inspection techniques and the use of measuring instruments.
• Experience with incoming inspection and vision measuring systems is an advantage.
• Basic knowledge of Quality analytical tools and problem-solving techniques.
• Experience with SAP and MES (Manufacturing Execution Systems) is preferred.
• Ability to read and comprehend technical drawings and specifications.
• Knowledge of applicable cleaning, hygiene, and quality requirements.

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: 62693

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.