In this role, you have the opportunity
to be part of our 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. 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.
You are responsible for
Performing activities like assessing quality plans, product designs and reviewing test and other performance data, analyzing market feedback, leading root cause analysis and quality problem solving
Ensuring validation of key quality requirements like: usability, reliability, product performance, manufacturability, safety, security, privacy, serviceability, sustainability etc.
Providing 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 mostly for Hardware Products and Consumables
Act as a single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every PRP milestone
Performing independent technical assessment on product quality performance and post market product analysis
Leading quality related problem solving and root cause analysis during design and manufacturing phases
Using post-market analytics and statistics to report on product quality performance in the field (providing feedback to manufacturing, suppliers or design teams) and initiating field actions when required
Being the single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
Contributing to improvements for our existing Quality Management System Elements
Organizing internal and external audits, making sure that Audits run successfully and taking care about Audit follow-up activities to improve Products and QM-System
Applying Lean Management tools and daily problem solving
You are a part of
our Medical Consumables and Sensors(MCS) team which is a dynamic business that provides Philips Healthcare customers with advanced lifesaving medical technology.
Also, you are part of our renewed structure: As a result of Philips ongoing 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.
To succeed in this role, you should have the following skills and experience
Engineering degree in a Technical discipline or equivalent professional qualification and experience
3+ years industrial experience at best in Medical Device, Pharmacy, Aerospace, Bio Science or similar regulated industry
Working knowledge of regulatory standards including at a minimum ISO 13485,US CFR 21 Part 820, IEC 60601-1, IEC 62304 and ISO 14971
Demonstrated effectiveness in independently investigating issues and moving them towards resolution
Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (EU-MDR) will have on Manufacturers and Notified Bodies.
Organized/structured work approach
Strong English communications skills, written and verbal
High reliability and quality focus
High engagement, motivation and flexibility
Sociable team member supporting all Philips colleagues
This role may require 10-15% travelling
Education/Experience in the quality, compliance or regulatory area, preferably in a healthcare environment
Basic German communication skills, at least verbal
Experience in a regulated industry environment
Knowledge of quality Standards/tools/techniques and analysis methods
Experience in an international environment
Have a working understanding of LEAN and six sigma concepts, methodologies and deployment
In return, we offer you
Working in the medical industry which brings much fulfillment, as well as unique opportunities to grow. 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.
We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
Philips encourages people with a disability to apply.
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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there,you can also learn about our recruitment process , or find answers to some of the frequently asked questions .