Position Summary: We are seeking Quality Engineer 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 :

CAPA Initiation & Writing Draft and initiate CAPAs per internal procedures and regulatory requirements Define scope, issue, risk impact, and acceptance criteria

CAPA Investigation Conduct root cause analyses using tools like 5 Whys, Fishbone, FMEA Collect and document supporting evidence; conduct technical interviews

Action Planning & Implementation Develop effective, timely action plans with responsible parties Coordinate implementation across functions: engineering, validation, microbiology, etc. Define and document effectiveness checks

CAPA Closure Verify and document completion and effectiveness of actions Ensure all documentation is audit-ready and compliant with QMS

Documentation & Quality Systems Use electronic CAPA platforms (Track Wise, Master Control, EtQ Reliance, etc.) Ensure compliance with Good Documentation Practices (GDP) Participate in CAPA boards and quality review meetings

Regulatory & Technical Expertise:

Deep understanding of medical device regulations: 21 CFR Part 820, ISO 13485, ISO 14971, MDR 2017/745, ICH Q9/Q10 Experience with FDA inspections and Notified Body audits Strong grasp of CAPA systems and identifying systemic issues

Education & Experience Requirements: Bachelor’s degree in Mecahnical or Electrical Engineering is required. 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,Quality Process, Quality Assurance process execution.