Position Summary: We are seeking a CAPA Engineer (Technical Writer) to support our Quality Control Department, with a focus on the Corrective and Preventive Action (CAPA) process. The selected candidate will manage all phases of the CAPA lifecycle—including initiation, investigation, implementation, and closure—in alignment with FDA, ISO, and global regulatory standards. This role requires collaboration with cross-functional teams to address deviations, non-conformances, and audit findings using a structured, traceable, and well-documented approach. Strong technical writing skills and a solid understanding of medical device regulatory requirements are essential. Location: Eastern Region, Puerto Rico

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 Electric Engineering or Mechanical 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 process execution.