€ 60,000 - € 80,000
Quality & Safety
Detachering via YER
Medical & Health, Manufacturing
Over deze vacature
The challenge is to take innovative consumer products to the market, in a competitive environment.
Philips Personal Health is one of two sectors within Royal Philips, delivering Personal Health and Wellbeing solutions. This sector builds on a deep understanding of people’s needs and aspirations to create innovations that support wellbeing.
The Innovation Site Eindhoven (ISE) delivers Innovation and Development of medical and non-medical devices to the Personal Health business. ISE is responsible for product research, development, industrialization and post market activities.
The ISE Quality and Regulatory team ensures that all products meet relevant regulations and standards, performance and reliability requirements and Philips policies. The Safety & Compliance Manager ensures that the products that are developed meet both internal and external standards and regulations, and that the products are safe to use for the most vulnerable end-users (babies and infants).
You are responsible for informing the product development teams what standards and policies the products need comply to, supporting the project team in doing safety risk analysis, and ensuring that the right compliance evidence is in place before release to market.
The focus is the beauty business, specifically the lumea range of intense pulse light devices.
As a Safety & Compliance manager you will:
- Lead all safety/regulatory affairs to ensure that the products/business comply with all regulatory requirements and Philips policies;
- Manage safety and approbation teams/labs/activities;
- Carry out root cause analysis in case of safety and non-compliances according 8D approach;
- Implement all relevant regulatory requirements in development projects, OEM ODM products and verify and validate designs regarding these requirements;
- Facilitate risk assessments;
- Lead projects with significant safety and regulatory content;
- Establish relationships with certification bodies worldwide (such as Dekra or UL) and coordinate the approbation process via these certification bodies;
- Report and discuss trends in product roadmaps that could require pro-actively lobbying or building up knowledge about requirement or establishing relationships with authorities and/or certification bodies.
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
You will be part of the Q&R team that consists of approximately 40 team members working for the businesses- Mother & Child Care, Skin Care, Health Measuring 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 welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to Philips.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
- Academic degree in biomedical, material, mechanical, or chemical engineering or equivalent by proven experience;
- Proven track record (>5 yrs.) in product development of durable consumer and/or medical products (must have);
- Experience in Safety & Compliance domains in international, multi-disciplinary, consumer product development projects (must have);
- Proven analytic capabilities and product knowledge;
- A network oriented mindset and ability to interact with all business functions at all levels;
- Project management experience/skills;
- Conceptual, analytically strong, data driven, and also hands-on personality;
- A strong leader and a team player. You are an excellent communicator and motivator, skilled in managing interpersonal processes;
- Courageous and able to continuously challenge the status quo, with a strong desire to improve organizational effectiveness structurally;
- Always looking for perfection. You don't accept underperformance or poor results. You have a quality mindset.