Quality Engineer - Pms

Stryker

Hybrid
Complaint intake and management
Regulatory reportability assessment
Adverse event reporting
Stryker is seeking a Quality Engineer with expertise in Post-Market Surveillance, complaint handling, and quality management systems to join their hybrid work environment. The ideal candidate should have a degree in engineering and 2-5 years of relevant experience, particularly in the medical device sector

Job Summary

  • Perform preliminary complaint intake, management, and event classification, assessing complaints for regulatory reportability.
  • Prepare and submit MDR, MIR, vigilance, and global adverse event reports, achieving zero late submissions.
  • Collaborate closely with stakeholders and team members, providing guidance and coaching to drive engagement and performance.

Matching Summary

Match Score: 85

Stryker is seeking a Quality Engineer with expertise in Post-Market Surveillance, complaint handling, and quality management systems to join their hybrid work environment. The ideal candidate should have a degree in engineering and 2-5 years of relevant experience, particularly in the medical device sector.

Skills & Requirements

Must-have

  • Complaint intake and management
  • Regulatory reportability assessment
  • Adverse event reporting
  • Post-Market Surveillance requirements
  • Quality Management Systems knowledge

Nice-to-have

  • Strong analytical and problem-solving skills
  • Effective communication with senior leadership
  • Proactive customer support
  • Medical Device Risk Management understanding

Key Requirements

  • 2-5 years experience
  • 1-2 years in Medical Device domain
  • 1+ years in complaint handling or customer quality
  • BE/BTech/ME/MTech in Bio Medical / Mechanical / Electrical Engineering

Work Rights

Not specified

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