Principal Design Quality Assurance Specialist

7 days ago


Suzhou, Jiangsu, China Philips Full time

**Job Title:** Senior Design Quality Engineer

Job Summary:

We are seeking a skilled Senior Design Quality Engineer to join our team at Philips. This role will be responsible for ensuring the quality and safety of our medical devices, from design to delivery.

About the Role:

  • Develop and implement quality management systems to ensure compliance with regulatory requirements.
  • Supervise new product introduction (NPI) projects and implement design controls.
  • Lead cross-functional teams to develop quality engineering documentation and ensure its implementation.
  • Define and review quality and regulatory requirements for products.
  • Ensure product-development processes and documentation meet quality system requirements.
  • Manage the design history file and ensure its accuracy and completeness.
  • Lead internal and external audits to ensure compliance with regulatory requirements.

Requirements:

  • BS/MS in Engineering or equivalent experience.
  • Minimum 5 years of quality assurance experience, with a focus on design control and new product development.
  • Strong knowledge of regulatory requirements, including ISO 13485, FDA 820, and ISO14971.
  • Excellent communication and problem-solving skills.
  • Fluent English, both written and spoken.

About Philips:

We are a health technology company dedicated to improving people's lives through meaningful innovation. Our team is passionate about delivering high-quality products that make a difference in people's lives.

What We Offer:

  • A challenging and rewarding role with opportunities for growth and development.
  • A collaborative and dynamic work environment.
  • Competitive salary and benefits package.

How to Apply:

If you are a motivated and experienced quality engineer looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].



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