The Quality Control Inspector/Technician, is responsible for overseeing and executing quality operations related activities, including measurement, and testing at Incoming quality. To ensure that the incoming inspection operations complies with the products quality standards, per BIOTRONIK specifications under cGMP and Quality System rules.
The Quality Control Inspector/Technician, who is stationed in a Clean Room environment, will assists in overseeing the incoming inspection operations, obtaining and analyzing the quality data for materials/components related controls.
Your Responsibilities
- Oversee the incoming inspection operations based on cGMP and Quality System requirements.
- Perform inspection or operational processes compliance against the established procedures, work instructions, drawings and/or specifications.
- Timely disposition of Non-conformities, including the blocking of products for further investigation.
- Perform mechanical, visual, functional inspection, which including but not limiting to: Raw materials, components, fabricated/manufactured parts & assemblies, to ensure all quality aspect of the delivered parts met the specifications and requirements.
- Responsible for supporting First article/First Piece approval process and prioritize daily and weekly inspection based on planned scheduled.
- Labeling, inventory, and bookings of data and defective product storage locations in accordance with the QM specifications.
- Generate detail inspection records for incoming materials lots, and non-conformance report as necessary.
- Training and certification of inspection specifications in accordance with inspection specifications
- Continuous monitoring and planned verification of issues, processes, etc. on QM specifications compliance, in the corresponding production area.
- Management of Inspection Records and other documents which may require archiving.
- Support 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, mechatronic, or other engineering discipline or equivalent.
- At least 2 years of experience in quality technician role in a regulated manufacturing environment 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 CMM, smart scope, vision measuring system preferred.
- Basic Quality Analytical Tools.
- Experience with SAP and MES preferred (Manufacturing Execution Systems).
- Comprehending Technical Drawings.
What we offer
- being encouraged to think and act entrepreneurially
- working in global teams and projects
- developing yourself professionally
