Director, Quality Assurance - Regulatory
Core
Strategic and operational quality leadership for an enterprise-wide specimen collection kit program, ensuring compliance with FDA and ISO standards across the kit lifecycle.
Role type
Director, Quality Assurance – Regulatory (Medical Devices)
Builds
Compliant specimen collection kits for diagnostic and clinical programs
Domain
Diagnostics / Medical Devices / Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System design and governance, FDA 21 CFR 820 compliance, ISO 13485 compliance, Risk management, CAPA program management, Supplier quality oversight, Audit leadership, Change control, Complaint handling, Metrics reporting
Preferred skills
Laboratory developed tests knowledge, CLIA framework familiarity, Strategic thinking, Cross-functional influence without direct authority, Inspection and audit experience
Technologies
21 CFR 820, ISO 13485
Responsibilities
Provide enterprise-wide quality governance for specimen collection kits, Design and maintain a robust Quality Management System, Oversee kit lifecycle processes including design controls and risk management, Lead internal and external audits and regulatory inspections, Partner with Regulatory Affairs to align quality and regulatory strategies, Oversee external vendor and supplier quality, Establish and monitor quality metrics and dashboards, Drive a culture of quality and continuous improvement
Seniority
Director, strategic leadership with hands-on technical oversight