POSITION SUMMARY:

We are seeking a CAPA Engineer (Technical Writer) to provide expert support to the Quality Control Department at Medtronic Juncos, specializing in the Corrective and Preventive Action (CAPA) process. The successful candidate will ensure each phase of the CAPA lifecycle—initiation, investigation, implementation, and closure—is managed in strict alignment with FDA, ISO, and global regulatory standards.
You will collaborate with cross-functional teams to manage deviations, non-conformances, and audit findings with a structured, well-documented, and traceable approach. This position requires strong technical writing skills and a thorough understanding of medical device regulatory requirements.
Key Responsibilities:

EDUCATION & EXPERIENCE REQUIREMENTS:

• Bachelor’s degree in engineering, Life Sciences, Biotechnology, or a related field
• 3+ years of experience managing CAPAs in the medical device industry
• Regulatory audit experience (FDA, ISO, EU)
• Quality certifications (CQE, CAPA Specialist, Lean Six Sigma) – a plus

TECHNICAL & PROCESS KNOWLEDGE:

• Familiarity with medical device manufacturing processes
• Understanding of validation protocols (IQ, OQ, PQ)
• Experience with statistical tools (e.g., Minitab, advanced Excel)

KEY SKILLS & COMPETENCIES:

• Excellent technical writing in English and Spanish
• High attention to detail with a strong compliance mindset
• Strong communication and project coordination skills
• Ability to manage multiple priorities under strict deadlines
• Team-oriented with initiative and independence
  Join us in contributing to the advancement of safe, effective medical devices by ensuring quality system integrity through expert CAPA process execution

Please refer the Job description for details