Senior Quality Engineer

FITS LLC

Juana Diaz, Puerto Rico
On-site
Quality systems (capa's, fmea's)
Product transfer, injection molding
Microsoft excel data migration
FITS LLC is seeking a Senior Quality Engineer in Juana Diaz, Puerto Rico, to manage quality systems and lead quality investigations in the Medical Device or Pharmaceutical industry. The ideal candidate should possess a Bachelor’s degree in Engineering or Science, be bilingual in Spanish and English, and have at least five years of relevant experience

Job Summary

  • Lead and support quality investigations including NCRs, complaints, and quality feedback, ensuring proper root cause analysis and resolution.
  • Develop, implement, and monitor Corrective and Preventive Actions (CAPA) to prevent recurrence of quality issues.
  • Ensure compliance with Quality System Regulations (QSR), GMP, safety policies, and regulatory standards while supporting training and quality.

Matching Summary

Match Score: 85

FITS LLC is seeking a Senior Quality Engineer in Juana Diaz, Puerto Rico, to manage quality systems and lead quality investigations in the Medical Device or Pharmaceutical industry. The ideal candidate should possess a Bachelor’s degree in Engineering or Science, be bilingual in Spanish and English, and have at least five years of relevant experience.

Skills & Requirements

Must-have

  • Quality Systems (CAPA's, FMEA's)
  • Product Transfer, Injection molding
  • Microsoft Excel data migration
  • Root cause analysis and resolution
  • Quality investigations including NCRs
  • Develop, implement, and monitor CAPA
  • Evaluate and analyze quality reports

Nice-to-have

  • Treat everyone like family
  • Customer service pro
  • Full of bright ideas
  • Eager to innovate
  • Top-quality results

Key Requirements

  • Bachelor's Degree in Engineering or Science
  • Five (5+) years of experience
  • Bilingual: Spanish and English
  • Problem solving and effective persuasion skills

Work Rights

Not specified

Tailored Resume

Cover Letter