Quality Engineer I

AbbVie

Alajuela, Costa Rica
**
Quality system and gmp/iso standards
Risk management and analysis
Process capability and validation
** AbbVie is seeking a Quality Engineer I for their Electrophysiology division in Alajuela, Costa Rica. The role involves ensuring compliance with quality system requirements and collaborating on process and product validation activities, primarily in the medical device sector. **

Job Summary

  • As the Quality Engineer I, you will work closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators.
  • Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).
  • Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.

Matching Summary

Match Score: 75

** AbbVie is seeking a Quality Engineer I for their Electrophysiology division in Alajuela, Costa Rica. The role involves ensuring compliance with quality system requirements and collaborating on process and product validation activities, primarily in the medical device sector. **

Skills & Requirements

Must-have

  • Quality System and GMP/ISO standards
  • Risk management and analysis
  • Process capability and validation
  • NCMR, OOT, and MA investigations
  • Document Change Requests
  • Quality Plans and Reports
  • IQ, OQ, PQ, and PPQ execution

Nice-to-have

  • Career development opportunities
  • Great place to work recognition
  • Diversity and inclusion focus

Key Requirements

  • Bachelor’s Degree in STEM
  • 0-3 years of experience
  • Proficiency in MS Excel, Word, PowerPoint
  • Knowledge of statistical data analysis
  • Knowledge in process improvement tools
  • Knowledge with control of nonconforming material
  • Knowledge of FDA, GMP, and ISO 13485 regulations
  • Advanced command of English language

Work Rights

Not specified

Tailored Resume

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