长沙招聘

  

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

  

    

  

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

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

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

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

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

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

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

8. Be responsible for DHF(Design History File) Review

9. Ensure the of deliverable Design transfer sufficiency and effectiveness

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

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

12. 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.

  

 

  

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