Do you want to help shape the future of healthcare? Our name, Siemens Healthineers (SHS), was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
We offer you a flexible and dynamic environment with opportunity to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting?
Then come in and join our ASEAN team as Quality Officer (6-month Contract) to cover a colleague going on maternity leave.
Your tasks and responsibilities:
- You will assist in product registration – timely submission of In-Vitro Diagnostic (IVD) new product registration and amendment of approved products to obtain approval in shortest time. This will include compiling and submission and handling of additional request through the Health Sciences Authority (HSA) online portal.
- You will handle post-marketing requirements for IVDs and Medical Device (MDs) by going through the Siemens Healthineers tool for product complaints and submit to HSA where required. Handling of reportable field corrective action with HSA on online tools and with Business Line (BLs) on SharePoint.
- You will handle update of process for Quality and EHS management system. Requesting for SOPs to be reviewed as needed according to process. This will include liaising with the various process owners.
- You will handle the required licenses with NEA of the new products besides the dosimeter coordination with the Customer Service Engineers and Apps and the National Environment Agency (NEA) radiation exposure report.
- You will handle the tool for safety incident investigation and liaising with the reporting party.
- You will be responsible for documentation of control drugs supply in IVD
Your qualifications and experiences:
- You are currently pursuing a Degree in Science or Biochemistry or related courses.
- You have knowledge of MD registration requirements and amendments in Singapore and previous experience of submission in Medics Online (HSA) website would be an advantage.
- You have knowledge of MD post marketing requirements in Singapore and previous experience of OSCAR submission in HSA website would be an advantage.
- General knowledge of Singapore GDPMDS requirements would be an advantage.
- Previous experience on LicenseOne application with NEA would be an advantage.
- Knowledge of corrective and preventive actions or even fishbone analysis (cause & effect) will be useful.
- Contract Period: 6 months from Sept 2021 to Mar 2022
- Location: Singapore
Our global team:
Siemens Healthineers is a leading global medical technology company. 65,000 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.
Our culture embraces different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here (https://talent.siemens.com/stayconnected) to get started.
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
Organization: Siemens Healthineers
Company: Siemens Healthcare Pte Ltd
Experience Level: Early Professional
Job Type: Full-time