PURPOSE OF THE POSITION
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 and Associate Quality Engineers in collecting and analyzing the quality data and ensuring the quality standard in the production floor.
ESSENTIAL JOB FUNCTIONS
- 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 and Associate 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 the creation of inspection specifications in SAP - Inspection plan.
- Support the receiving of incoming materials and coordination of any deviations in consultation with Q engineer.
- 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 an regulated environment (eg: medical devices, aerospace, or automotive industry) will be an advantage; or prior work experience in a technical area or manufacturing environment with strong affinity for Quality Control
- Quality Inspections techniques
Special knowledge, expertise, experience
- Quality Inspections techniques and experiences in handling measuring instruments
- Basic Quality Analytical Tools
- Experience with SAP preferred (Manufacturing Execution Systems / MES will be an advantage)
- Comprehending Technical Drawings
- Cleaning and Hygiene Regulations
- Preferred ISO 13485 Internal auditor
Basic: up to $2200
- Chinese / Male or Female
- Clean room (Preferred)
- SAP experience
- Quality in Medical device material
Working hours: Shift 2: Mon to Fri, 3.15pm to 11pm (+$180 Shift Allowance)