Posted by Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Junior Quality & Technology Executive (Contract)
Job Description:
- Product Registration:
- Prepare In-Vitro & In-Vivo medical devices related submissions not limit to CSDT and change notification according to regulatory requirements from Medical Device Authority, MoH.
- Submit required documentation/information to local authorities such as Medical Device Authority,
- MoH, SIRIM QAS Sdn Bhd & Atomic Energy & Licensing Board.
- Report to Medical Device Authority, MoH in a timely manner on post market surveillance activities such as Adverse Event Reporting & Field Safety Corrective Action (FSCA).
- Prepare and maintain registration of wireless telecommunication components/devices (e.g. Bluetooth, ultra-wide band, wireless footswitches) with SIRIM QAS.
- Provide administrative support on all QT related tasks.
- Quality Management System:
- Support as internal auditor and perform internal audit based on the internal audit schedule (shared role).
- Perform service notification review (shared role).
Qualifications and experiences:
- University degree in natural sciences (for example biomedical, pharmaceutical studies or medical engineering) or equivalent.
- At least 1 year of work experience in the field of regulatory affairs or equivalent.
- Well experienced in MS Office.
- Fluent in English & BM both written & spoken.
- Meticulous and detail orientated.
- Able to work independently.