Faith Herniman

Results-driven Quality Assurance professional with over nine years of experience in regulated manufacturing environments, specializing in ISO 13485, FDA, and Health Canada compliance. Adept at leading CAPA investigations, internal audits, and continuous improvement initiatives to uphold product quality and safety. Seeking a challenging quality leadership role where I can apply my expertise in QMS management, cross-functional collaboration, and regulatory compliance to support operational excellence and ensure industry-leading standards.

ISO 13485 & Regulatory Compliance Expertise:
Nine years of experience managing Quality Management Systems (QMS) in regulated manufacturing environments, including ISO 13485, FDA and Health Canada regulations. Proven success in hosting audits, maintaining certifications, and driving audit readiness across departments.

CAPA & Non-Conformance Management:
Skilled in coordinating and leading CAPA and non-conformance investigations, including root cause analysis, corrective action implementation, and trend reporting. Experienced in facilitating CAPA/NC board meetings and tracking KPIs for continuous improvement.

Audit Leadership & Certification Maintenance:
Acted as a representative during internal and external audits. Maintained site certification by proactively identifying gaps and implementing process improvements aligned with ISO standards and organizational goals.

eQMS & Documentation Control:
Experienced in managing quality documentation and document control systems within electronic QMS platforms. Skilled in creating, reviewing, and approving quality records, SOPs, workflows, and change controls.

Cross-Functional Collaboration:

Collaborates effectively with Operations, Complaint Management, R&D, and other cross-functional teams to resolve quality issues, enhance compliance, and support order fulfillment processes.

Continuous Improvement & Quality Culture:
Champion of quality-first mindset through initiatives such as Kaizen events, quality gemba walks, and process standardization. Track record of leading improvement projects that reduce risk and enhance operational efficiency.