Philips is a leading global healthcare company aiming to improve the lives of 3 billion people by 2025. We strive to make the world healthier and more sustainable through innovation developed across a broad range of Imaging, Information and Monitoring systems. With nearly 40,000 employees working in 100 countries, we are committed to helping create meaningful moments of care, whether in the hospital room, the living room or the boardroom.
Being a part of Philips Healthcare means having an opportunity to drive your career in an organisation where there is incredible diversity across function, skill and geography. We are a fascinating business to be a part of – a global leader in our chosen fields with a strong emphasis on creating impact through meaningful innovation.
Facilitate the implementation of the ongoing regulatory activities for Philips’ ECR devices
Action on any related QA activities in accordance with the documented procedures
Participate in continuous improvement and efficiency initiatives within the QMS
Comply with Quality Management System
Support in key areas of quality and compliance such as: Complaints, Post Market activities, and audit
Interact with the manufacturing group to ensure post market requirements are met.
The overall experience necessary to succeed in the role includes:
Minimum 1-2 years' experience in Quality Assurance or similar role with experience in a medical device or highly regulated environment
Tertiary qualifications in Engineering / Science, or a related discipline
Previous experience in Computer System Validation is highly desirable
An understanding of ISO13485 , FDA CFR 21 part 820 and Good Manufacturing Practice (GMP) requirements
Knowledge of a wide range of manufacturing technologies and disciplines
Working knowledge of a document management system
Advanced computer skills in Microsoft Office Suite
In addition, you will:
Have excellent communication skills
Have a strong technical writing skills
Be highly proactive, collaborative and self-motivated with ability to work effectively both individually as well as part of a team
Work with other cross functional teams to provide support, solve problems and implement solutions
Be a strong team player
The work we do at Philips changes lives for the better. It's not just innovation for the sake of innovation. It's innovation for the sake of people. For us, it's about helping communities everywhere and addressing the big issues head on.
We offer a competitive salary, on-going training and development opportunities, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.