Quality Engineer; CAPA)

We are looking for a Quality Engineer (CAPA).

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, escal... [text truncated due to original input truncation]
• 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.
• 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 (Track Wise, Agile, Veeva, or equivalent),
  Class II/III implantable or combination device experience, CQE/CQA.