Quality Engineer/specialist

FITS LLC

Añasco, Puerto Rico
On-site
Audit observations
Investigations
Capa activities
Initiate NRs as required and perform investigations in ETQ for NRs/CAPAs and Audit Observations for Operations

Job Summary

  • Initiate NRs as required and perform investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.
  • Identifies and escalates compliance issues to Operations Managers for effective resolution.
  • Provides leadership and guidance to cross-functional teams to ensure sound corrective/preventive actions are implemented.

Matching Summary

Initiate NRs as required and perform investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.

Skills & Requirements

Must-have

  • Audit Observations
  • Investigations
  • CAPA activities
  • FDA 21 CFR
  • GMP & GDP regulations
  • Bilingual (Spanish and English)

Nice-to-have

  • Customer service pro
  • Innovative thinker
  • Leadership skills

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 4+ years of experience in regulated industry
  • Bilingual: Spanish and English

Work Rights

Must have PR status

Tailored Resume

Cover Letter