Gap Assessment and Remediation
- Quality Management System improvement and compliance
- Retrospective DHF construction
- Business process and Quality System evaluation
- Audit preparation
Performed CAPA system assessment, leading to improved process that removed ambiguity and inconsistency in decision making and prioritization. Mentored CAPA owners in root cause analysis and DMAIC-based project execution.
Results: Eliminated extensive CAPA backlog. Achieved full compliance with QMS procedures.
Conducted deep-dive assessment of acquired company’s quality system and product DHF for in-process PMA submission. Led prioritized remediation effort encompassing all design control elements.
Results: Contained cost and regulatory risk for subsequent 18 months, resulting in PMA approval.