Quality Engineer Design and Development
Core
Coordinate quality planning in product development and ensure consistent adherence to the development process for medical devices.
Role type
Quality Engineer (Design and Development)
Builds
Medical devices through partnerships with manufacturing companies
Domain
Medical technology / Regulated industries
Required skills
Quality management systems (ISO 9001, ISO 13485, FDA QMSR, ISO 14971), Design verification and validation, Risk management, Supplier evaluation and qualification, Supplier audit planning and execution, Development documentation review, Cross-functional collaboration
Preferred skills
Internal auditor qualification, Validation and qualification activities experience, Regulatory requirements knowledge for medical devices
Technologies
ISO 9001, ISO 13485, FDA QMSR, ISO 14971
Responsibilities
Coordinate quality planning in product development, Perform quality-related tasks and document/phase reviews, Support design input/output, verification, validation, changes, and transfer activities, Create and review development documentation and risk analyses, Prepare and approve verification and validation plans including software validation, Evaluate and qualify suppliers, Plan and conduct supplier audits, Assess supplier change notifications, Collaborate with Purchasing, Pilot Production, and Supplier Quality teams
Seniority
Mid-level, hands-on IC