Senior Staff Quality Engineer
Core
Senior Staff Quality Engineer ensuring FDA 21 CFR 820 and ISO 13485 compliance for continuous glucose monitoring (CGM) medical devices.
Role type
Senior Staff Quality Engineer (Medical Device)
Builds
Audit-ready quality systems and regulatory compliance frameworks for CGM products
Domain
Medical Device / Biosensing Technology
Deliverable
client delivery
Required skills
FDA 21 CFR 820, ISO 13485, Design Control, Corrective and Preventive Actions (CAPA), Data Analysis (Excel, JMP), Technical Documentation Review
Preferred skills
Cross-functional stakeholder influence, Strategic initiative leadership, Systemic gap identification
Technologies
Excel, JMP
Responsibilities
Drive inspection readiness programs including mock audits and documentation preparedness; Lead complex investigations and implement corrective actions; Participate in internal audits and external regulatory inspections; Mentor engineers on compliance best practices; Establish and monitor audit readiness metrics.
Seniority
Senior Staff, hands-on IC with strategic mentorship