Sr Engineer

• Take ownership of assigned CAPAs and all related activities, from initial issue assessment and containment through root cause investigation, action plan execution, implementation verification, effectiveness checks, and closure, in accordance with ISO 13485:2016 (Clauses 8.5.2/8.5.3) and 21 CFR 820.100.
• Support CAPA process acceleration by driving assigned records toward committed due dates, reducing cycle time and aging, escalating blockers promptly, and ensuring cross-functional task owners complete assigned actions.
• Lead structured root cause investigations using methodologies such as 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis, and 8D/DMAIC, documenting conclusions with clear and defensible technical rationale.
• Author comprehensive investigation reports and CAPA documentation designed to meet FDA, Notified Body, and internal audit requirements. Strong technical writing skills are essential.
• Ensure assigned records are complete, accurate, traceable, and contemporaneously documented within the electronic Quality Management System (eQMS), maintaining data integrity and Good Documentation Practices (GDP).
• Support Quality System updates resulting from CAPA activities, including revisions to SOPs, work instructions, forms, Device History Records (DHRs), and inspection methods.
• Partner cross-functionally with Manufacturing, Operations, R&D, and Supplier Quality to implement corrections and corrective/preventive actions and verify that changes do not adversely affect finished product or patient safety.
• Define and execute effectiveness-check methodologies, applying statistical techniques and trend analysis of nonconformance, complaint, and audit data to confirm sustained resolution.
• Present CAPA record status and progress during CAPA Review Board meetings.

Qualifications

Required:

• Bachelor's degree in Engineering.
• 5-7 years of relevant professional experience.
• Experience managing CAPAs and conducting structured root cause investigations.
• Strong technical writing and Quality System documentation skills.
• Knowledge of ISO 13485:2016 and 21 CFR 820.100.

Preferred:

• Experience with an eQMS platform such as TrackWise, Agile, Veeva, or equivalent.
• Experience supporting Class II/III implantable or combination medical devices.
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification.