Advance Quality Engineer

Orthopedicjobs

Hybrid
Risk management as per iso 14971
Quality management systems expertise
New product development process experience
Primarily responsible for risk management and risk assessment as per ISO 14971, including FMEAs, quality plans, and technical documentation

Job Summary

  • Primarily responsible for risk management and risk assessment as per ISO 14971, including FMEAs, quality plans, and technical documentation.
  • Leads product quality related projects and supports process validation programs for new product development.
  • Partners with operations and vendors to maintain a robust supply chain and resolve manufacturing and quality issues.

Matching Summary

Primarily responsible for risk management and risk assessment as per ISO 14971, including FMEAs, quality plans, and technical documentation.

Skills & Requirements

Must-have

  • Risk management as per ISO 14971
  • Quality Management Systems expertise
  • New product development process experience
  • Supplier selection and validation
  • GMP and ISO 13485 compliance
  • Quality data trending and analysis

Nice-to-have

  • Analytical and problem-solving skills
  • Multi-national team collaboration
  • Excellent communication and presentation skills
  • Expert knowledge of industry standards
  • Project delivery in AQE function

Key Requirements

  • Bachelor's in mechanical, biomedical, or biotech engineering
  • 2 to 6 years relevant work experience
  • Knowledge of ISO 14971, IEC 62366, 60601-1 standards
  • Understanding of ISO 13485 and 21 CFR 820
  • Travel up to 20%

Work Rights

Not specified

Tailored Resume

Cover Letter