Staff Development Quality Engineer
Core
Lead projects and provide technical/quality system guidance for Design/Development Quality, ensuring compliance with design controls and regulatory requirements.
Role type
Staff Development Quality Engineer (Quality Engineering)
Builds
Design verification and validation deliverables, risk management plans, and quality system documentation for new products.
Domain
Healthcare / Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls expertise, risk management (FMEA, product risk analysis), statistical techniques, regulatory compliance (US FDA), cross-functional collaboration, project leadership, technical mentoring
Preferred skills
Master's Degree, advanced statistical analysis, software development support
Technologies
None explicitly stated
Responsibilities
Identify and lead projects requiring custom risk-managed execution plans; provide technical guidance on establishing design controls requirements; support design verification and validation activities including protocol and report review; perform risk evaluation and management activities; act as SME for statistical techniques; participate in technical and management reviews; support process validation activities; drive best practices for requirements and design verification.
Seniority
Staff, hands-on IC with leadership responsibilities