In this role, you have the opportunity to
- Lead the Quality, Reliability and Safety of Medical Devices.
- Contribute to achieve quality objectives as they relate to
- Customer experience (voice of the customer)
- Complaint Rate (Cost of Non-Quality, Recalls, Complaints, DEFOA)
- First Past Yield (avoid scrap, rework).
- Work from within an independent Q&R organization with key stakeholders of the Business during the various stage of the design, development and maintenance of the Medical Device.
You are responsible to
- Independent oversight of the performance of product, within the project, as this relates to Product Quality, Safety and Reliability.
- Management insights on the status and plans for assigned responsibilities and goals. Bring issues in a timely and constructive fashion to attention of management (escalate when needed).
- During (early) Development and Lifecycle Maintenance:
- Participate in establishing the quality and reliability strategy within the project specific to the product(s) in scope:
- Involved in quality target setting in Project Charter
- Challenge and ensure target / requirement settings are challenging and balanced (realistic)
- Act as a product quality lead by defining in the Product Quality Plan, in consultation with the project team, the activities to be performed to meet product quality targets and reporting on these activities.
- Contribute to the execution and delivery of results specific to product quality:
- Review reliability plans and ensure this covers all phases of the project
- Review key quality related requirements like: Usability, reliability, product performance, manufacturability, safety, security, privacy, serviceability, sustainability etc.
- Ensures a proper transfer of design specifications to manufacturing, supply chain and service
- Performs assessment on the design/architecture on suitability for the quality criteria.
- Review key Product related deliverables like: Reliability Reports, Reliability modelling for predictive analysis, FMEA’s, Change Point Analysis.
- Applies and facilitates data driven Design for Quality & Reliability best practices in the Project like:
- FMEAs, robust design, V&V, root cause analysis & problem solving
- Continuous Improvement:
- Regularly go through the history of quality issues (leverage data of post-market analysis like Complaints, Quality Notifications, DeFOA, Defect). Learn from them and drive improvement (proposals).
- Support and lead quality related problem solving and root cause analysis as they relate to design and development.
- Define and establish best practices and leveraging from across the organization (locally and globally).
- Watch out for new techniques/methodologies to improve product quality, and analyze them and if appropriate plan to apply / deploy them in the organization.
- Own your personal development and support the development of others
- Proactively define your development goals and objectives.
- Support the development of others by means of coaching, training.
- Be open for feedback and provide open, honest and balanced feedback to others.
- Grow yourself. Feel confident to try something, make mistakes and learn from them.
You are a part ofYou will become part of the Q&R organization, supporting the Business Unit Magnetic Resonance Imaging (MRI) within Philips Healthcare, who is passionate about serving our customers and making a meaningful contribution to (product) quality.
MRI is responsible for marketing, product development and lifecycle management of 1.5T and 3T High end and Mid-range performance.
You will be based in China. Work in cross-functional project (core) teams consisting of amongst others R&D, Service, Industrialization. In addition, you will have the ability to interact across different sites as a benefit of being part of a global organization.
To succeed in this role, you should have the following background, basic skills or experience
- Bachelor degree with 10+ years of related experience or a Master degree with 8+ years of related experience.
- Experience in highly regulated and complex industry (medical device is a pre). Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR.
- Experience or understanding of specific quality tools, methods and standards (Weibull++, Minitab, reliability modeling, statistical analysis, warranty analysis, HALT, ALT, IEEE1624)
- Experience or understanding of Software or Hardware development, Data mining, Verification and Validation, Artificial Intelligence, Risk management, RCA, Requirements Management, Design, Usability
- Experience or qualification:
- Design for Six Sigma and Statistics or proven experience in problem solving and root cause analysis tools.
- Design for Six Sigma (Green Belt) / Robust Design Capabilities
- Design for Reliability
- FMEA (including FMEA facilitation)
- Usability, APQP, Design Form Manufacturing and Test (Foundation level of higher)
- Meddev awareness, AAMI Design Controls / Risk Management
- Program management (able to plan activities and track them to closure)
- Passionate and positive attitude. Strives for high performance and product quality.
- Demonstrated success in leading change for product quality and reliability.
- Ability to support development, manufacturing, field data analysis and develops intelligence in estimating current performance and future trends
- Proven ability to successfully incorporate and manage stakeholder needs throughout a project. Ability to build consensus at all levels including global interactions.
- Communicate globally, across teams and programs, from senior leaders to administrative support personnel.
- Composure, conflict management, timely decision making, listening skills, self-motivation, and perseverance are all requirements of this position.
- Detail oriented and able to see the big picture
- Excellent English skills, written and speaking.
In return, we offer youChallenging tasks on technical interesting and relevant Medical Device Products and/or accessories.
The opportunity to grow beyond initially assigned tasks/responsibilities for those with the right drive and skills.
A pleasant working environment with flexible working hours.
Our benefits are very competitive and designed around your preferences:
- A market conform salary
- A variable bonus based on both Philips results and personal performance
- Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
- Solid company pension scheme and attractive collective health insurance package
- Opportunity to buy Philips shares and products with discount
- Healthy work-life balance 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 .