Senior Design Quality Assurance Engineer

1 week ago


Suzhou, Jiangsu, China Philips Full time
Job Title: Senior Design Quality Assurance Engineer

Philips is seeking a highly skilled Senior Design Quality Assurance Engineer to join our team. As a key member of our Quality and Regulatory organization, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.

Key Responsibilities:
  • Maintain quality management system compliance by ensuring quality procedures are implemented and followed.
  • Supervise NPI (New Project Introduction) projects and implement design controls requirements.
  • Concentrate on CFR820.30 Design control and ISO13485, EU MDD/MDR, MDSAP, ISO 14971 Risk Management, IEC62304 Software development lifecycle, IEC60601, IEC62366 Usability Engineering, and other relevant regulations.
  • Be responsible for design control in NPI/Sustaining Project/lifecycle management Quality Assurance.
  • Work with cross-functional groups to develop quality engineering documentation and lead its implementation.
  • Define and review quality and regulatory requirements for products within the design process.
  • Ensure product-development processes and documentation meet Quality System requirements.
  • Key member of product defect management board, engineering change board, and risk management activities.
  • Conduct project gate audits and provide support to project teams.
  • Find improvement opportunities and initialize process and product quality/reliability/usability improvements.
  • Be an expert in design control and lead Design Control process improvement and maintenance.
  • Participate in decision-making processes for product-quality related decisions.
  • Provide process training to required trainees.
  • Lead, prepare, and participate in internal and external audits.
  • Facilitate CAPA when design control related.
Requirements:
  • BS/MS in Engineering or equivalent experience.
  • Strong quality assurance management experience, minimum 5 years in quality assurance.
  • Strong design control and new product development experience.
  • Strong statistical and analytical abilities.
  • Professional knowledge in ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP.
  • Professional knowledge in product safety standards.
  • Strong communication, problem-solving, and continuous improvement skills.
  • Fluent English in writing and speaking.
  • Experience in medical industry or high-regulated industry (preferred).
  • Strong influence, presentation, and dispute-solving skills.
About Philips:

We are a health technology company that believes every human matters. We are committed to making a meaningful contribution to quality healthcare for all. If you're passionate about serving our customers and making a difference, join our team and do the work of your life to help the lives of others.



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