Global Quality Assurance Partner for Medical Devices

5 days ago


Suzhou, Jiangsu, China Philips Full time

Company Overview


We are Philips, a global leader in health technology dedicated to improving the lives of billions worldwide. Our mission is to create meaningful solutions that make a real difference.



About This Role


This position offers an exciting opportunity to join our team as a Global Quality Assurance Partner for Medical Devices. The successful candidate will be responsible for ensuring the quality and compliance of medical devices supplied to us from our vendors.



Job Description


The ideal candidate will have at least 5 years of experience in quality assurance or a related field, with a strong background in medical device regulations. They will work closely with our suppliers to ensure they meet our quality standards and comply with relevant regulations.



Key Responsibilities:



  • Participate in supplier sourcing and selection process
  • Lead APQP, Process capability study, SPC, DOE for process optimization
  • Support project teams for DFMEA assessment
  • Collaborate with R&D teams to define CTQ and CTS
  • Represent Philips QMS requirements to Suppliers
  • Implement purchasing controls as per PEPF procedures
  • Support Design for Excellence 'DfX' collaboration between R&D and Supplier
  • Proactively monitor and measure product/process quality and performance trends and troubleshoot production/release issues
  • Develop and oversee system/element/part qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations
  • Assure quality systems of OEMs, manufacturers and suppliers are maintained and acceptance criteria are in alignment with component/product use and customer expectations
  • Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes
  • Serve as internal and supplier quality auditor, managing planning, execution, reporting and closure of audits and audit findings


Requirements


To succeed in this role, you will need:



  • A minimum of 5 years of related engineering experience (medical device or regulated industry preferred)
  • Wide-ranging experience within an engineering function
  • Well-versed in Quality Engineering and Continuous Improvement techniques
  • Direct working relationships with suppliers
  • Participated in several NPIs from start to finish
  • Direct shop-floor production engineering sustaining experience
  • Works on assignments of high complexity where analysis of situations/data requires evaluation of new factors
  • Applies judgment in selecting methods and techniques
  • Resolves problems independently
  • Receives little to no guidance on routine work, general guidance on new assignments
  • Works on assignments of moderate scope and with accountability for functional impact
  • Applies technical and soft skills as a seasoned professional
  • Interacts often with other internal functions and external partners at a level up
  • Provides detailed guidance to others periodically
  • Focus of influence primarily within own function


What We Offer


We offer a competitive salary range of $120,000 - $180,000 per year, depending on your location and experience, plus benefits such as career growth opportunities, a friendly work environment, and hybrid work flexibility.



About Working at Philips


At Philips, we value diversity, equity, and inclusion. We strive to create a workplace where everyone feels valued, respected, and empowered to contribute their best work. Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and customers.



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