Quality Engineer in Nanjing at Stryker Corporation

Date Posted: 8/7/2018

Job Snapshot

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Job Description

Responsible for developing, applying, revising, and maintaining quality standards/procedures to support manufacturing activities. Making sure the GMP and ISO13485 requirements are implemented correctly and followed strictly.

  • Continuously fully comply with all GMP standard /ISO 13485 requirements.
  • Maintain the local Quality system and implement all quality requirements. Conduct monitoring and trend analysis for Quality System implementation in the assigned areas.
  • Ensure sufficient processes are in place and being followed for the transfer, production, sustaining, and monitoring of product quality
  • Provide guidance on Quality Assurance/GMP/FDA-QSR related topics.
  • Responsible to stop further processing in the event of encountering non-conforming products condition.
  • Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment
  • Develop, coordinate and/or implement root cause problem solving, preventive and corrective actions. Analyzes reports and/or returned products and recommends corrective action. 
  • May conduct and support Internal and External audits.
  • Provide support on Quality procedure set up and validation to product transfer and assist during new product development.
  • Be the system owner for QS based on authorization.
  • Release RM/Component/Product at first level based on authorization.

Work From Home: No

Travel Percentage: Up to 25%

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