Regional Lead Quality Engineer
Core
Ensure new product development for combination products follows a 21 CFR Part 4 compliant quality system with emphasis on Design Control across the entire product lifecycle.
Role type
Regional Lead Quality Engineer (Combination Products/Medical Devices)
Builds
Compliant quality systems and design controls for combination product development projects
Domain
Medical Devices / Combination Products / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control process expertise, Risk analysis (FMEA), Statistical data analysis, Sampling plan development, Vendor audit management, SOP/WI development, Six Sigma problem solving
Preferred skills
Drug-delivery combination product experience, Embedded software/mobile app integration knowledge
Technologies
21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, FDA guidance
Responsibilities
Provide quality guidance and oversight to combination product development projects ensuring regulatory compliance; Ensure external partners meet CSL standards and participate in vendor audits; Report progress and escalate risks to management; Drive implementation of compliant quality systems and process improvements; Maintain systems and databases for combination products; Apply Six Sigma methods to resolve issues
Seniority
Senior, hands-on IC with leadership oversight
