System Design Quality Engineer

Philips
Shanghai
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringExperience: 2+ yearsEducation: bachelorsSkills: ["Continuous improvement","Root cause analysis","Stakeholder management","Mentorship","Documentation management"]

Create and execute process validation strategies and lead the full design control lifecycle, from design inputs through verification, validation, and design transfer. Maintain quality engineering documentation and quality plans for hardware, software, and systems, ensuring regulatory compliance. Drive quality improvement and risk management across the product lifecycle using post-market surveillance data, performance reviews, root cause analysis, and CAPA to prevent recurrence and prepare for audits and inspections.

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FursaFursa
Philips
Philips
1 month ago

System Design Quality Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 27 days agoStatus: Live

Job Summary

Create and execute process validation strategies and lead the full design control lifecycle, from design inputs through verification, validation, and design transfer. Maintain quality engineering documentation and quality plans for hardware, software, and systems, ensuring regulatory compliance. Drive quality improvement and risk management across the product lifecycle using post-market surveillance data, performance reviews, root cause analysis, and CAPA to prevent recurrence and prepare for audits and inspections.
Location: Shanghai
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Create and execute process validation strategies using statistical tools to support transition of new products to production while meeting quality and regulatory standards.
  • •Manage the end-to-end design control process, including eliciting and validating design inputs, and overseeing verification/validation and design transfer.
  • •Maintain and update quality engineering documents and quality plans for hardware, software, and systems to ensure accuracy and regulatory compliance.
  • •Conduct design and system assessments using performance data and root cause analysis to identify and address quality deficiencies.
  • •Run risk management and CAPA processes across the product lifecycle, using post-market surveillance insights to drive corrective actions and continuous improvement, including audit readiness.

Key Requirements

  • •Bachelor's or Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
  • •Minimum 2 years of experience in Quality Engineering, Safety Engineering, R&D Engineering, or equivalent (or no prior experience required with a Master's Degree).
  • •Preferred: Bachelor's or Master's in Mechanical, Electrical, or Biomedical Engineering.
  • •Preferred experience: 8+ years in the medical device industry in R&D, quality, or safety engineering roles.
  • •Preferred certification: Six Sigma Green Belt.
Experience:2+ yearsMedical device industry
Education:Bachelor's in Mechanical Engineering, Electronics Engineering, Science (or equivalent)
Skills:Continuous improvementRoot cause analysisStakeholder managementMentorshipDocumentation management
Certifications:Six Sigma Green Belt
Tech Stack:Statistical tools

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