For CL/ISE we are looking for a QA manager
To assure the Quality and Safety of Innovative (Medical and Non-Medical) products in a Dynamic Environment.
Key challenges include risk management, design quality assurance activities and co-ordination of quality activities with Engineering, procurement, manufacturing, clinical, service and support teams. Supports organization to work compliant in a lean way.
• Instruct, coach and facilitate project team’s w.r.t Innovation Site Eindhoven-Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.).
• Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
• Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements
• Create quality function deliverables as per Innovation Site Eindhoven –Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
• Review Requirements Management process and outcome.
• Reviews Product Verification and Validation.
• Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
• Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.
• Ensures timely execution and required communications and escalation.
You will be part of the Q&R team consisting of approximately 30 team members working for the businesses- Mother &Child Care, Skin Care, Connected Health Devices & Pain Relief reporting to the QAM Group lead. You will be based in Eindhoven, The Netherlands. You will work in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across Philips.
We are looking for
• Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Preferably experience in a medical device industry.
• Proven ability to successfully incorporate and manage stakeholder needs throughout a project
• Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
• Both detail oriented and able to see big picture
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
We would like to invite professionals and freelancers to contact us.
We will offer a competitive benefits package in line with the seniority of the position.
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
Philips Personal Health delivers lifestyle solutions for personal well-being. Our brand promise is Innovation & You. We aim to develop innovations that make a meaningful difference to people’s lives. The sector builds on a deep understanding of people’s needs and aspirations to create innovations that help consumers achieve their lifestyle ambitions.
Innovation Site Eindhoven is part of Innovation & Development (I&D) of Personal Health. It focuses on the development of medical and non-medical lifestyle products in the areas of Mother & Child Care, Pain Relief, Skin Care and Personal Health Solutions. The site is responsible for the development and realization of new product propositions. Innovation Site Eindhoven is looking at a very challenging growth task to bring more new ideas, and increasingly digital innovations and services, to the global market. At Innovation Site Eindhoven, improving well-being is our passion, creating awesome consumer experiences through real-life solutions. We are an honest and inspirational team, daring to be different.
A key department in this site is Product Research, Consumer Care and Clinical. This function represents the Voice of the Consumer in our Innovation & Development activities. It drives the translation of powerful insights into products and services that delight consumers better than competition and live up to Philips’ brand promise of Innovation & You. The influence of the department spans from Insight generation / concept development to market launch and forms a main link between I&D and the business. You will work in a team of Product Researchers, Clinical Scientists and Consumer Care experts.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer +31 0655724609
Werken voor Yacht
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Uiteraard staat deze vacature open voor zowel mannen als vrouwen.