In this role, you have the opportunity to

• Ensure that design meets compliance standards, quality management system and regulatory requirements

• Be responsible for Verification & Validation activities (planning, execution and deliverable) review and approval for confirming design outputs comply with requirements of design inputs.

You are responsible for

• Ensure that design meets compliance standards, reliability and quality management system requirements

• Ensure design processes compliance to Philips QMS procedures/work instructions, including local process/procedure development as appropriate.

• Be responsible for quality planning of local design control management system e, transfer and maintenance.

• Design review on mandatory for SV(start verification) and RFD(ready for release) phase, as one of core team members and independent reviewers

• Take part in Risk (SRA/DRA/PSRA) assessment as risk management team member

• Be responsible for Verfication&Validation activities (planning, execution and deliverable) review and approval for confirming design outputs comply with requirements of design inputs.

• Be responsible for change request review, including judgement for final disposition of defect tracking

• Be responsible for DHF(Design History File) Review

• Ensure the of deliverable Design transfer sufficiency and effectiveness

• Be responsible for Design and/or Device Master Record change review & approval

• Act as CAPA facilitator for product related CAPA, Product type CAPA (ownership, facilitation and/or contribution)

• Product quality improvement and assist in problem solving

You are a part of

?Professional DQE Team, with multiple team peers globally.

To succeed in this role, you should have the following skills and experience

? Education: Bachelor degree, major in science or engineering discipline is preferred.

? Experience: More than 3 years’ experience in quality engineering or quality management in medical device industry. More than 2 years’ experience in design and development quality management for Class II & III active medical device

? Fluent in English and Chinese Languages is required.

? Competencies and Skills:

? Sufficiently understand medical device regulatory and standards, especially for MDD 93/42/EEC or EU-MDR, QSR part 820, China GMP and ISO 13485.

? Appropriate awareness of medical device industrial standard, such as IEC60601, GB9706 and ISO 14971

? Be familiar with product design and development process & critical phase, prefer for IDP or CMMI etc.

? Be familiar with typical control measures and methodology for design quality and product quality, prefer for DFSS or GB.

? Prefer for knowledge of project management.

? Strong logical thinking

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.

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.

上班地址：科技北三路飞利浦金科威大厦

所属部门：Healthcare 飞利浦医疗保健事业部
飞利浦医疗保健事业部积极响应中国政府进行医疗改革的号召和举措，秉承创新精神和全程关护的理念，致力于帮助改善目前中国面临的看病贵、看病难的问题。我们的传统业务集中在高端市场，是中国高端医疗设备市场的三大主要供应商之一。为了响应中国的新医改关于加强基层医疗卫生机构建设的号召，更好地服务于基础医疗市场（主要是二级及以下的医院,社区/城镇医疗卫生中心,私立医疗机构等），飞利浦于2009年投资5，400万美元在苏州建立医疗影像基地，研发并制造符合中国市场需求的、为本地医院量身定制的影像系统；并于2011年成立了专门服务基础医疗市场的“基础医疗业务部”，向本地市场提供价格合理、质量优良的医疗设备和解决方案。目前在中国拥有27家办事处，覆盖了中国的大多数省份，拥有4，000多名员工。