Quality Technician, Vascular Intervention
6 months ago
Quality Technician, Vascular Intervention
BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.
The Quality Technician provide support to Quality management and Contamination Control in the areas of Documentation/Records management and Training. He/ she also supports Microbiological laboratory for routine operations including collections of samples, cleaning and preparation work in the laboratory in accordance to written procedures and regulations. He/she also provides support to Quality Engineer in performing incoming inspection for material. The successful candidate ensures good documentation and testing performed as per BIOTRONIK specifications under cGMP and quality system rules.
Your Responsibilities
Scanning and archival for Quality records ( DHR) which submitted to quality department Assist in updating training status into LMS Learning Management System Support microbiological and/or environmental monitoring testing, perform the cleaning and preparation work for the test, collect environmental monitoring samples To perform administrative tasks such as assisting in the maintenance of records and ordering reagents, media, and other consumable items to make sure the laboratory in well stocked Cleaning and maintaining equipment inside the laboratory Support the receiving of incoming materials, conduct incoming inspection for material and coordination of any deviations in consultation with Quality engineer. Support, execute projects and any others quality related activities as directed by supervisorYour 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 (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 cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820 Intermediate proficiency in MS Office ( MS Word, MS Excel, Outlook) Experience with SAP preferred Quality Inspections techniques and experiences in handling measuring instruments Basic Quality Analytical Tools Comprehending Technical Drawings Cleaning and Hygiene Regulations-
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