Packaging/Medical Device Quality Engineer
Core
Ensure new product development for CSL combination products and medical devices follows a 21 CFR Part 4 compliant quality system, serving as a subject matter expert on FDA/MDR regulations and Design Control processes.
Role type
Medical Device and Packaging Quality Engineer (IC)
Builds
Combination products and medical device constituent parts for patient care
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, Risk Analysis, Statistical Data Analysis, Sampling Plan Development, Root Cause Analysis, Vendor Audit Management, SOP/WI Development, Regulatory Compliance (21 CFR 820/Part 4, ISO 13485, ISO 14971, EU MDR), Validation/Verification (V&V), Usability/Human Factor Studies
Preferred skills
Drug-delivery combination product development, Embedded software, Mobile/web apps, Connected health solutions
Technologies
21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, FMEA, DHFs
Responsibilities
Ensure design development teams follow Design Controls and utilize quality engineering techniques; Support vendor management activities by participating in audits and reviewing quality agreements; Provide progress reports and escalate risks to management; Assist with development and implementation of the quality system and update processes; Maintain systems/databases related to combination products; Conduct root cause analysis and problem solve issues.
Seniority
Mid-Senior, hands-on IC
