Quality Technician (Night shift)

Your tasks

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.

• 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.

Requirements

• 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.