Job Title Design Quality Engineer Job Title Design Quality Engineer Your challenge 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 Job Responsibilities o Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production meeting quality and regulatory standards working under limited supervision o Handles the entire design control process from eliciting and validating design inputs to managing verification validation and smooth design transfer ensuring rigorous adherence to regulatory and quality standards o Keeps a check on the drafting and updating of detailed quality engineering documents including quality plans for hardware software and systems ensuring all documentation is accurate up-to-date and compliant with regulatory requirements o Ensures success of quality improvement projects by integrating quality reliability and Post Market Surveillance PMS insights into all stages of the product lifecycle driving continuous enhancement of product quality and reliability o Conducts thorough assessments of product and system designs reviews performance data and performs root cause analysis to identify and address quality deficiencies ensuring the highest standards of design excellence o Validates critical design inputs such as usability reliability performance manufacturability and safety ensuring alignment with both quality standards and regulatory requirements o Guides comprehensive risk management activities throughout the product lifecycle ensuring potential risks are accurately identified assessed and effectively mitigated to uphold product safety and quality o Leverages post-market performance data to assess product effectiveness in the field providing actionable feedback to manufacturing and design teams and initiating corrective actions when necessary o Ensures preparation for quality audits and inspections maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards o Records manages and executes CAPA processes including problem identification root cause analysis and implementation of solutions to prevent recurrence and drive continuous improvement o Applies continuous improvement techniques to enhance quality practices ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle o Builds effective relationships with internal and external stakeholders providing guidance and mentorship to ensure alignment with quality standards and project milestones Your team As a result of Philips renewed commitment to Quality it has recently restructured its organization to ensure you and your department have explicit 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 Minimum Required Qualifications Education Bachelor s Master s Degree in Mechanical Engineering Electronics Engineering Science or equivalent Work Experience Minimum 8-10 years of experience with Bachelor s in areas such as Quality Engineering Safety Engineering R D Engineering or equivalent OR 5 years experience required with Master s Degree Preferred Qualifications Six Sigma Green Belt Preferred Skills Technical Functional Skills o Design Quality Management o Data Analysis Interpretation o Design for Quality DFQ o Root Cause Analysis RCA o CAPA Methodologies o Regulatory Requirements o Privacy Safety and Security Risk Assessment o Technical Documentation o Continuous Improvement o Product Quality and Reliability o Defect Management o Design Verification Planning o Design Validation Planning o Product Test Design About Philips We are a health technology company We built our entire company around the belief that every human matters and we won t stop until everybody everywhere has access to the quality healthcare that we all deserve Do the work of your life to help the lives of others Learn more about our business Discover our rich and exciting history Learn more about our purpose How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers We are embracing an approach wherein we spend more time together than apart Our commitment to inclusion and diversity At Philips we provide equal opportunities to all our employees and to all eligible applicants for employment in our company irrespective of age color disability nationality race religion gender sexual orientation LGBTQ and all aspects that make individuals unique Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2 5 billion people a year by 2030 through meaningful innovation We have fair transparent and clear employee policies which promote diversity and equality in accordance with currently applicable law For we believe that life is better when youareyou Our hybrid working model is defined in 3 ways We believe in the importance of impactful collaboration There s a certain energy when everyone s in the same room that can heighten idea generation and creative friction needed for problem-solving We embrace flexibility Choosing where when and how to work can vary according to task and team schedules Flexibility isn t office or online it means choosing the space that works best for you your teams and our customers on a case-by-case basis We want to be at our best The way we work and our workspaces are designed to support our well-being offer career advancement opportunities and enable us to be at our best 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 innovative customer-first health technology solutions Help us improve the health and well-being of billions of people every year Ultimately creating a career that no one could have planned for Even you