Senior Design Quality Engineer

Philips
Suzhou
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringExperience: 2+ yearsEducation: bachelorsSkills: ["Communication","Problem-solving","Leadership","Teamwork","Stakeholder management"]

Lead design quality activities for medical device products, driving design controls, validation, risk management, and CAPA across the product lifecycle to ensure regulatory compliance and continuous improvement. Collaborate with cross-functional teams on hardware, software, and systems quality, while applying data-driven methods and post-market insights to elevate product reliability.

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FursaFursa
Philips
Philips
6 months ago

Senior Design Quality Engineer

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Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 10 days agoStatus: Live

Job Summary

Lead design quality activities for medical device products, driving design controls, validation, risk management, and CAPA across the product lifecycle to ensure regulatory compliance and continuous improvement. Collaborate with cross-functional teams on hardware, software, and systems quality, while applying data-driven methods and post-market insights to elevate product reliability.
Location: Suzhou
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Sr. Manager level

Key Responsibilities

  • •Create and execute comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards.
  • •Handle the entire design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer with regulatory compliance.
  • •Draft and update quality engineering documents, including quality plans for hardware, software, and systems, ensuring accuracy and regulatory alignment.
  • •Integrate quality, reliability, and Post Market Surveillance (PMS) insights into the product lifecycle to drive continuous improvement in quality and reliability.
  • •Conduct design assessments, review performance data, perform root cause analysis, and implement corrective actions to address quality deficiencies.

Key Requirements

  • •Bachelor's or Master’s degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
  • •Minimum 2 years of experience with a Bachelor's in areas such as Quality Engineering, Safety Engineering, R&D Engineering or equivalent OR no prior experience required with Master's degree.
  • •Preferred Six Sigma Green Belt
  • •Minimum required Education: Bachelor’s / Master’s Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
  • •Minimum required Experience: Minimum 2 years of experience... OR Master’s degree with no prior experience.
Experience:2+ yearsHealthcareMedical devices
Education:Bachelor's
Skills:CommunicationProblem-solvingLeadershipTeamworkStakeholder management
Certifications:Six Sigma Green Belt
Tech Stack:Statistical toolsData analysisCAPADesign for QualityRCA

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn