Do you want to contribute to the future of healthcare? As Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever evolving healthcare industry that truly makes us unique as an employer.
We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone in order to grow both personally and professionally. Sound interesting?
Then come in and join our Malaysia SH team as Quality Executive (12 Months Contract) to support both Laboratory Diagnostics (In-Vitro) & Imaging (In-Vivo) medical devices related regulatory submissions & implementations of quality management systems.
Your mission and responsibilities:
- You will identify, analyze and implement country specific regulatory requirements related to In-Vitro & In-Vivo medical devices
- You will plan and prepare In-Vitro & In-Vivo medical devices related submissions according to regulatory requirements
- You will submit required documentation / information to local authorities such as Medical Device Authority (MDA), MoH and SIRIM QAS Sdn Bhd
- You will report to local authorities in a timely manner on post market surveillance activities such as Adverse Event Reporting & Field Safety Corrective Action (FSCA)
- Experience in registration of wireless telecommunication components/ devices (e.g. Bluetooth, ultra-wide band, wireless footswitches) with SIRIM QAS would be an added advantage
- You will maintain certification to ISO 9001, other national regulatory standard/ guidelines such as Good Distribution Practice Medical Devices (GDPMD) and Atomic Energy Licensing Board (AELB) and any other standards which might deem necessary
- You will maintain and ensure effective cooperation with both internal and external stakeholders to ensure effective implementation of the organization's Quality and EHS Management system
- You will involve in analysing process workflow and propose improvements to management
- You will promote quality awareness throughout the organization
To find out more about the specific business, have a look at https://www.healthcare.siemens.com/
Your qualifications and experiences:
- You have University degree in natural sciences (for example biomedical, pharmaceutical studies or medical engineering) or equivalent
- You have at least two (2) years of working experience in regulatory affairs for medical devices and Good Distribution Practice Medical Devices (GDPMD)
Your personality and skills:
- You are proficient in computer skills, including Microsoft Office suite (Microsoft Word, PowerPoint, Outlook and Excel).
- You are meticulous and detail oriented
- You have a good command of written and spoken English and Bahasa Melayu.
- You are able to communicate effectively with internal and external customers in all mediums of communication.
- You are self-directed and able to work with minimal supervision
Being part of our team:
Siemens Healthineers is a leading global medical technology company. More than 53,000 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.
Your cultural fit:
Our unique team spirit arises from embracing 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 want you to seek, implement and celebrate your best ideas.
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 Sdn. Bhd.
Experience Level: Mid-level Professional
Job Type: Full-time