Quality Engineer
Core
Supports and coordinates Design Control activities across the product lifecycle, ensuring compliance with regulatory processes and driving effective execution of product development.
Role type
Mid-level Quality Engineer (Medical Devices)
Builds
Product development lifecycle compliance, quality plans, and risk management frameworks
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control processes, Design Verification and Validation, Risk Management, Design History File management, Quality Management System (QMS) tools, Continuous improvement methodologies, Contractual and regulatory requirement verification, Project quality planning
Preferred skills
Engineering Procure Construct (EPC) tendering knowledge, Global project initiative participation, Cross-functional collaboration, Data analysis and prioritization
Technologies
QMS tools, Design Control software
Responsibilities
Coordinate Design Control activities across the product lifecycle; Verify contractual and regulatory requirements in Engineering Procure Construct phases; Establish and execute project quality plans and witness-points; Partner with cross-functional teams to identify gaps and resolve issues; Act as a resource for colleagues with less experience; Lead local improvement projects
Seniority
Mid-level, hands-on IC with some autonomy
