Target PR Range: 41-51/hr DOE
Summary
Take personal ownership of assigned individual CAPAs and all related processing – from issue assessment and containment through root cause, action plan execution, implementation verification, and effectiveness check closure – in compliance with ISO 13485:2016 (Clauses 8.5.2/8.5.3) and 21 CFR 820.100.
Support overall CAPA process acceleration: drive assigned records to committed due dates, reduce cycle time and aging, escalate blockers early, and hold cross-functional task owners accountable.
Lead structured root cause investigations using 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis, and 8D/DMAIC, documenting conclusions with clear, defensible technical rationale.
Author high-quality investigation reports and CAPA documentation that withstand FDA, Notified Body, and internal audit scrutiny – strong technical writing is a core requirement of this role.
Ensure documentation compliance across all assigned records: complete, accurate, traceable, and contemporaneous entries in the eQMS, with full data integrity and GDP adherence.
Support Quality System updates and modifications, including revisions to SOPs, work instructions, forms, DHRs, and inspection methods resulting from CAPA actions.
Partner with Manufacturing, Operations, R&D, and Supplier Quality on the floor to implement corrections and corrective/preventive actions, and confirm actions do not adversely affect finished product or patient safety.
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Define and execute effectiveness check methodology, applying statistical techniques and trend analysis of NC, complaint, and audit data to confirm sustained resolution; present record-level status at the CAPA Review Board.
Preferred: eQMS experience (TrackWise, Agile, Veeva, or equivalent), Class II/III implantable or combination device experience, CQE/CQA.
Education/Experience
Bachelor’s degree in engineering required.
5-7 years experience required.
