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As part of the Quality Engineering 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. Make sure that new regulatory requirements like MDR is implemented timely.
You are responsible for
Develop comprehensive quality, reliability, and Post Market Surveillance (PMS) plans for all stages of the product life cycle
Design Quality Plans for hardware and software, ensuring compliance with relevant quality, safety, and regulatory standards at every milestone
Validate key design inputs, covering usability, reliability, performance, safety, security, and more
Provide effective oversight of quality and reliability plans, Risk Management activities, and design-related processes throughout the product/system lifecycle
Conduct independent technical assessments to lead problem-solving and root cause analysis during design and manufacturing
Support stakeholders during quality system and product audits and inspections
You are part of:
Join the Quality Engineering department dedicated to supporting patient monitoring products and solutions. We champion worldwide product approval and compliance with all applicable regulations and requirements.
To succeed in this role, you should have the following skills and experience
Degree in mechanical engineering, electrical engineering, or applied sciences, or equivalent professional training experience
Several years of experience in the medical device sector or a similarly highly regulated industry
Knowledge of Standards like ISO13485, ISO14971; IEC60601-1, 62366, 62304, with a pragmatic approach to application and execution
Proven ability to independently investigate and resolve problems effectively
Organized, structured, and creative work approach
Strong focus on product reliability and quality
High engagement, motivation, and flexibility
Sociable team player with a cooperative communication style.
Excellent communication skills in both English and German, written and oral
In return, we offer you
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech company, you will be responsible for successfully dealing with and managing Philips relationships with different stakeholders. 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 and Integrity above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.
Non-tariff-based compensation
Annual salary adjustments and bonuses
30 days of annual leave
Purpose: Doing meaningful work with a great team
Hybrid work concept: Up to two days a week "working from home"
Philips Pension Fund: Employer-funded pension plan
Mobility and devices: Leasing bicycles, cars, and also smartphones for private use
Culture: Informal culture, a paid day for voluntary work, various team/cultural activities (on sustainability, diversity, ...), etc.
Philips University: Wide range of professional training courses and for personal development
Philips MyShop: Discount on Philips products
Philips in Balance: Various offers for physical and mental health and sports courses
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