Every action is an opportunity to improve.
Over de functie
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Can you take a pro-active yet pragmatic and incremental approach to ensure compliance with Quality Systems and regulations that govern product development activities within the department?
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). As Quality Engineer Software you:
• Support and facilitate the department in enabling and assuring that products are developed and produced in compliance with requirements from applicable standards (process focus);
• Act as single point of contact within a project for compliance related questions;
• Give guidance and actively contributes to all aspects related to quality, applicable regulatory requirements and Philips HealthTech policies and procedures;
• Embed Quality & Regulatory requirements in the design and build processes;
• Monitor that the QMS procedures are followed, does everything needed to facilitate the team in following them;
• Support in applying requirements of applicable standards (ISO13485, IEC62304, ISO14971, IEC60601);
• Make a substantial contribution to ways of combining Agile with medical software development;
• Able to develop own competences further, assesses which aspects require further research and works out the form this should take.
We are looking for someone with a…
• Bachelor’s engineering degree with ? 6 years of related experience in (networked) product development, or a Master’s degree with ? 4 years of related experience, at least 2 years in a quality related role
• 6+ years of related experience in a medical device or non-regulated industry
• Relevant work experience in product software development with demonstrable focus on quality and acting as a quality engineer;
• Excellent understanding of medical device development and in driving quality and regulatory challenges regarding US and EU medical device regulations (i.e., 21 CFR 820, MDD);
• Proven track record with development methodologies like Agile/Scrum/V-Model;
• Working knowledge of the IEC62304 standard is preferred;
• Experience with working in 10+ person multidisciplinary teams.
• Experience with supplier quality management is an advantage
• Influencing skills, coaching skills, hands-on approach
This role will appeal to you if...
• Enjoy working in cross-functional teams
• Are curious, open and feel at home in an international environment
• Have an affinity with innovative development projects and feel comfortable with relatively vague requirements
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies. This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
Our user-centered connected propositions contain re-usable components, within an increasingly open ecosystem. They also use current connectivity standards and cloud services. In short, they empower people. The Philips Connected Digital Propositions team of which you’ll be a part helps deliver best-in-class, end-to-end solutions. These include connected hardware, appliances, medical devices and wearables, and leading mobile apps across all major OS platforms. The team also develops various back-end cloud systems that integrate with these propositions.
The team works according to Agile principles, following SAFe (Scaled Agile Framework) processes. You will work on highly innovative, first-of-their-kind propositions that are new within Philips, so an entrepreneurial mindset is an advantage. Together with your team, you will strive for continuous improvement of deliverables, your way of working and yourself. The world doesn’t run from 9 to 5, so flexible working hours can be combined with a healthy work-life balance. Colleagues will challenge and coach you and you should willingly return the favor.
Voor meer informatie neem je contact op met Peter Groeneveld via telefoonnummer 06-53815170
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.