Advance Quality Engineer

Stryker Corporation

Gurugram, India
**
Risk management and assessment
Iso 14971 and fmeas
Quality management systems (iso 13485, 21 cfr 820)
** Stryker Corporation is seeking an Advance Quality Engineer in Gurugram, India, responsible for risk management, quality assurance, and collaboration with operations and suppliers for new product development. The ideal candidate will have a background in mechanical, biomedical, or biotech engineering, with extensive experience in quality management systems and new product development processes. **

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.
  • Lead product quality related projects and support the business in addressing and solving quality problems.

Matching Summary

Match Score: 75

** Stryker Corporation is seeking an Advance Quality Engineer in Gurugram, India, responsible for risk management, quality assurance, and collaboration with operations and suppliers for new product development. The ideal candidate will have a background in mechanical, biomedical, or biotech engineering, with extensive experience in quality management systems and new product development processes. **

Skills & Requirements

Must-have

  • Risk management and assessment
  • ISO 14971 and FMEAs
  • Quality Management Systems (ISO 13485, 21 CFR 820)
  • New Product Development (NPD) process
  • Supplier selection and validation
  • Quality data trending and analysis
  • Verification test strategies

Nice-to-have

  • Excellent communication and presentation skills
  • Ability to work with multi-national teams
  • Expert-level knowledge of industry standards
  • Delivered multiple projects in AQE function

Key Requirements

  • Bachelors in mechanical or biomedical or Biotech Engineering
  • 2 to 6 years of relevant work experience
  • Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards

Work Rights

Not specified

Tailored Resume

Cover Letter