As part of the Quality & Regulatory (Q&R) organization within Royal 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. 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 a COE, 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 well-being and care for people around world.
Ensures that appropriate quality plans are made and a suitable quality system is in place, for both New Product Introductions (NPI’s) as well as for ongoing manufacturing that include all stages of the development and manufacturing process of the product/system.
Organize internal and external audits, accompany and help that Audits run successfully as well as taking care about Audit follow-up activities to improve QMS systems.
Ensures validation of key quality requirements like: usability, reliability, product performance, manufacturability, safety, security, privacy, serviceability, sustainability etc.
Provides effective insight and oversight of the execution of the Quality Plan(s), Risk Management activities, and of all product quality related activities during pre- and post-release phase
Performs independent assessment on product quality performance throughout all phases of the project and post-launch product quality analysis during the monitoring phase
Provide oversight of Q&R NPI projects ensuring timely completion and compliance of project deliverables, consult corrective action of issues delaying completion and reporting on quality status of projects on department or site level.
Facilitate CAPA’S and support problem investigations and effective Corrective- and Preventive Action actions and programs.
Drive process improvements for certain Quality Management System Elements
Be part of applying Lean Management tools and daily problem solving
The Quality Engineering and Assurance department is part of the entire Quality & Regulatory department and supports patient monitoring products and solutions. We ensure world-wide product review, approval and compliance with all applicable Regulations and requirements.
We are looking for
Engineering degree in a Technical discipline or equivalent professional qualification and experience
Minimum of 5 years industrial experience at best in Medical Device, Pharmacy, Bio Science or similar regulated industry
Working experience with mastered regulatory compliance awareness, including ISO 13485, US CFR 21 Part 820, IEC 60601-1 and ISO 14971
Knowledge of quality standards/tools/techniques and analysis methods
Demonstrated effectiveness in independently investigating issues and moving them towards resolution
Organized and structured work approach
High reliability and quality focus
High engagement, motivation and flexibility
Sociable team member supporting all Philips colleagues
Experience in an international environment
Strong English and German communications skills, written and verbal
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech division, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). A person who is excited by new challenges, has strong technical competencies, and demonstrates resilience is most likely to succeed in these challenging, often demanding situations. However, by taking pride in all you do and inspiring others around you to prioritize Quality above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
Philips encourages people with a disability to apply. Part time possible.