Associate Quality Engineer, Combination Products
Core
Support quality oversight for the design, development, manufacture, and regulatory approval of combination products to ensure compliance with global quality system requirements.
Role type
Associate Quality Engineer (Combination Products)
Builds
Combination product development projects
Domain
Medical device / Biotechnology / Combination products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control, risk management, verification and validation (V&V), change management, document review, DHF maintenance, vendor audit support, regulatory compliance (FDA/EU MDR), process improvement, investigation support, CAPA management, internal audit participation
Preferred skills
Combination product experience, drug delivery device experience
Technologies
21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR
Responsibilities
Participate in design control activities including risk management, verification, validation, and change management; assist with oversight of external development and manufacturing partners; support maintenance and continuous improvement of quality systems; identify and communicate quality-related issues and risks; support investigations, CAPAs, and nonconformance management; participate in internal audits and inspection readiness activities
Seniority
Associate, individual contributor
