Job Description

In our line of work, life isn\xe2\x80\x99t a given - it\xe2\x80\x99s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we\xe2\x80\x99re located. Creating impactful innovations like ours, doesn\xe2\x80\x99t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we\xe2\x80\x99re working at the pace of change to improve patient lives with diagnostic tools that address the world\xe2\x80\x99s biggest health challenges.The Sr QA Specialist for Radiometer is responsible for managing Quality Management System and to coordinate the monitoring and measurement of QMS effectiveness. It also must ensure documentation of all the activities comply with Radiometer policies and procedures & Shared OPCOs requirements.This position is part of the QA Commercial Shared Service Team located in the Radiometer office in Selangor and will be Hybrid position. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.You will be a part of the QA Commercial team and report to the Director QA Operation responsible for ensuring country, company, and Shared OPCOs compliance of QMS. If you thrive in a fast-paced environment, are used to playing a critical supporting and coordinating role and want to work to build a world-class efficient team that is part of a Global QA department and have interactions and stakeholders to connect with in a global scale - read on.In this role, you will have the opportunity to:

• Deploy and maintain local Quality Management System for Malaysia GDPMD compliance and plan and conduct Quality System Management reviews initiated by Radiometer in relation to Shared OPCOs.
• Plan and manage Quality Systems processes and related deliverables (key performance indicators) in relation to the Shared OPCOs objectives and regulatory requirements.
• Manage and conduct internal quality audits, channel partner, and supplier audits. Co-ordinate for the customer complaint, corrective and preventive action, field action, adverse even reporting processes with Shared OPCOs QA.
• Support the Supplier Management Process. Support & co-ordinate local Quality Documentation, including labeling management. Ensure Radiometer Malaysia is continuously compliant with the Shared OpCos Quality Policies and applicable regulatory requirements.
• Provide quality and regulatory compliance support to any projects. Ensure the quality and regulatory compliance activities are covered and deliverables are supplied to the project (quality agreements defined, validation performed, etc.).

The essential requirements of the job include:

• Bachelor\xe2\x80\x99s degree in technical or scientific related field preferred.
• A working knowledge of business processes is required, particularly in IVD/MD commercial activities, Distributors and Quality processes.
• Minimum 3 years Previous experience in Quality / use of Quality tools Certified auditor for ISO 9001 / 13485 Strong regulatory knowledge of MDA requirements of Quality Management System and GDPMDS Analytical, problem solving oriented, detail oriented.
• Strong written and communication skills in English and Malay, and comfortable working in a dynamic multi-functional environment.

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.#LI-VK2At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow\xe2\x80\x99s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what\xe2\x80\x99s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit .At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Danaher