Ingénieur(e) Qualification/validation

Stryker

Competitive salary; performance-based bonuses; com...
Hybrid
Equipment qualification (eq)
Computerized system validation (csv)
Building facilities utilities qualification (bfu)
This role is essential for ensuring systems and processes meet the highest standards of safety, performance, and compliance in a collaborative environment

Job Summary

  • This role is essential for ensuring systems and processes meet the highest standards of safety, performance, and compliance in a collaborative environment.
  • The engineer will plan, execute, and document qualifications for equipment, computerized systems, and facilities while maintaining robust records in ValGenesis.
  • Stryker offers horizontal hierarchies, competitive salaries, comprehensive benefits including health insurance and retirement programs, and opportunities for career development.

Matching Summary

This role is essential for ensuring systems and processes meet the highest standards of safety, performance, and compliance in a collaborative environment.

Salary

Competitive salary; Performance-based bonuses; Comprehensive benefits package

Skills & Requirements

Must-have

  • Equipment qualification (EQ)
  • Computerized system validation (CSV)
  • Building facilities utilities qualification (BFU)
  • FAT SAT IQ OQ EQ MSA documentation
  • FDA ISO GMP regulatory compliance
  • Root cause analysis CAPA
  • Process capability analysis

Nice-to-have

  • ValGenesis eVLMS experience
  • Excel software validation
  • Cross-cultural collaboration skills
  • Continuous improvement mindset
  • Statistical sampling expertise

Key Requirements

  • Engineering degree or equivalent higher education
  • Experience with FDA ISO and GMP regulations
  • Proven track record in validation lifecycle management
  • Fluency in French and professional English
  • Knowledge of statistical tools like Gage R&R

Work Rights

Not specified

Tailored Resume

Cover Letter