Engineer 1, Quality System

Smith+Nephew

Batu Kawan, Penang, Malaysia
Iso 13485 lead auditor certification
Fda qsr 21 cfr part 820 compliance
Mdsap audit experience

Skills & Requirements

Must-have

  • ISO 13485 lead auditor certification
  • FDA QSR 21 CFR Part 820 compliance
  • MDSAP audit experience
  • CAPA process management
  • Change control procedures
  • Document control systems

Nice-to-have

  • Master's degree in related field
  • Internal auditing experience preferred
  • MS Project Gantt chart skills
  • Critical path analysis proficiency
  • HSE policy support experience
  • Continuous improvement initiatives

Key Requirements

  • Bachelor's degree in Science or Engineering
  • Minimum three years' quality engineering experience
  • Medical device manufacturing experience preferred
  • ISO 13485 lead auditor certification desirable
  • Proficiency in MS Word, Excel, PowerPoint, and Project

Work Rights

Not specified

Tailored Resume

Cover Letter