- 行业：医疗器械
飞利浦欢迎最新从事过医疗器械生产/质量管理等行业的优秀人才加入我们，飞利浦(中国)投资有限公司将为您提供广阔的发展平台！
In this role, you have the opportunity to
Support R&D team with their life cycle management activities for Philips’ X-ray imaging platform; focusing on the Chinese market. This involves being a confident advisor on safety, compliance, quality and reliability 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 responsible for
o Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
o Provides effective oversight of the execution of the Quality Plan, any Risk Management process activities, and of all design related activities
o Performs independent technical assessment on product quality performance and post-market product quality analysis
o Assures demonstrated compatibility with 3rd party products and local standardized components
o Lead quality related problem solving and root cause analysis during design and manufacturing to ensure that Product / System design meets quality and compliance standards for every milestone
o Post product launch, monitor field performance and if problems arise, work on failure root cause analysis, corrective action development and resolution verification.
o Act as single point of contact within the innovation development teams on product safety, quality, compliance and reliability engineering aspects
You are a part of
o a fast growing and innovative Quality Assurance/Quality Engineering team, within an ever-changing environment - constantly striving for improvements and exceeding internal and external stakeholder expectations.
To succeed in this role, you should have the following skills and experience
We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year. Specific skill requirements for this role include:
o Bachelor degree in technical field e.g. Mechanical, Electrical or Software Engineering with 10+ years’ experience in a highly regulated industry (preferably medical).
o Extensive Design Control experience with complex electrical/mechanical – software products.
o Quality Assurance and Quality Engineering experience for (medical) SW products.
o Understanding of Chinese medical device regulations, requirements, and standards like ISO 14971, IEC 62366 and IEC 62304. Preferably also knowledge of other global regulations and standards such as 21 CFR Parts 803, 806, 820 as well as ISO13485 and the EU-MDR.
o Knowledge of product reliability engineering is highly preferable.
o Possess a high-level of self-motivation and ability to work in a team. Ability to effectively manage time, organize and prioritize work, multi-task across many assignments is necessary. Effective interpersonal, written and oral communication skills expected.
o Excellent English skills, written and speaking.
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
o A market conform salary
o A variable bonus based on both Philips results and personal performance
o Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
o Solid company pension scheme and attractive collective health insurance package
o Opportunity to buy Philips shares and products with discount
o Healthy work-life balance
Why should you join Philips?
o 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.
o 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.
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