QMS Specialist

Philips
Shanghai
Workplace: HybridFull timeFunction: Quality & Regulatory (Non-Software)Experience: 4+ yearsEducation: bachelorsSkills: ["Root cause analysis","Problem-solving","Communication"]

Support the establishment and continuous improvement of a compliant Quality Management System (QMS). Contribute to developing and updating QMS documents such as SOPs and quality manuals, and help deploy processes across document control, training, and internal audits. Track non-conformance reports and QMS performance metrics, participate in root-cause and corrective action problem-solving, maintain quality records for audit readiness, and support risk management for regulatory compliance and QMS integrity.

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FursaFursa
Philips
Philips
2 months ago

QMS Specialist

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

Job Summary

Support the establishment and continuous improvement of a compliant Quality Management System (QMS). Contribute to developing and updating QMS documents such as SOPs and quality manuals, and help deploy processes across document control, training, and internal audits. Track non-conformance reports and QMS performance metrics, participate in root-cause and corrective action problem-solving, maintain quality records for audit readiness, and support risk management for regulatory compliance and QMS integrity.
Location: Shanghai
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Support deployment and continuous improvement of QMS processes in the assigned area, including document control, training, and audits, ensuring regulatory compliance.
  • •Collect, compile, and report QMS performance metrics (e.g., non-conformances, critical findings, training completion rates) to support management decisions.
  • •Contribute to continuous improvement by identifying opportunities to enhance efficiency and compliance and supporting implementation of improvements.
  • •Participate in internal audit planning by preparing documentation, assisting audit teams, and ensuring follow-up actions are completed.
  • •Maintain and archive quality records for audit readiness, collaborate with cross-functional teams on compliance inquiries, and support problem-solving with root-cause and corrective actions.

Key Requirements

  • •Vocational Education or a Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Science, or an equivalent field.
  • •No prior experience required with the degree OR minimum 4 years of experience in Quality Management Systems or Quality Audits.
  • •Experience in highly regulated industries/environments such as Med/Pharma/Automotive.
  • •Knowledge of regulatory requirements and quality management systems (QMS), including document control, training, and audits.
  • •Ability to analyze quality data (e.g., non-conformances, critical findings, training completion) and support root-cause and corrective actions.
Experience:4+ yearsHighly regulated environments
Education:Bachelor's in Mechanical Engineering, Industrial Engineering, Science
Skills:Root cause analysisProblem-solvingCommunication
Tech Stack:Quality Management Systems (QMS)SOPsQuality manualsDocument controlInternal auditsKPI monitoringData analysisCorrective actionsRisk management

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