Advance Quality Engineer

Stryker

Hybrid
Risk management and assessment
Fmeas
Quality plan development
Primarily responsible for Risk management and risk assessment as per ISO 14971, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File

Job Summary

  • Primarily responsible for Risk management and risk assessment as per ISO 14971, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File.
  • Partners with the operations team to develop and maintain a robust internal and external supply chain and assists vendors in resolving manufacturing and quality issues.
  • Lead product quality related projects and support the business in addressing and solving quality problems.

Matching Summary

Primarily responsible for Risk management and risk assessment as per ISO 14971, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File.

Skills & Requirements

Must-have

  • Risk management and assessment
  • FMEAs
  • Quality Plan development
  • Supplier selection and validation
  • Quality data trending and analysis
  • GMP and ISO 13485 compliance

Nice-to-have

  • Analytical and problem-solving skills
  • Effective cross-functional collaboration
  • Excellent communication and presentation skills
  • Multi-national team coordination

Key Requirements

  • Bachelors in mechanical or biomedical or Biotech Engineering
  • 2 to 6 years of relevant work experience
  • Experience in NPD process and new product development
  • Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards
  • Good understanding of Quality Management Systems (ISO 13485, 21 CRF 820)

Work Rights

Not specified

Tailored Resume

Cover Letter