The New Product Quality Engineer (Engineer II) ensures that new products are safe, effective, and compliant with applicable regulatory standards from early-stage R&D concepts to transfer to manufacturing and ultimately, product launch
Job Summary
The New Product Quality Engineer (Engineer II) ensures that new products are safe, effective, and compliant with applicable regulatory standards from early-stage R&D concepts to transfer to manufacturing and ultimately, product launch.
Key responsibilities include supporting early technology research, guiding project teams through Quality system requirements, and contributing to the development, review, and execution of protocols for design verification and validation.
This role actively supports qualification projects preparing risk assessments, protocols, reports, test scripts, and test reports to qualify production lines to manufacture the product at scale.
Matching Summary
The New Product Quality Engineer (Engineer II) ensures that new products are safe, effective, and compliant with applicable regulatory standards from early-stage R&D concepts to transfer to manufacturing and ultimately, product launch.
Skills & Requirements
Must-have
New Product Quality Engineering
Design Controls and Risk Management
Design Verification and Validation
Process Validation (IQ/OQ/PQ)
Design History File (DHF) creation
Nice-to-have
Customer Centricity
Data Savvy
Execution Focus
Technologically Savvy
Key Requirements
Minimum of 2 years working experience in medical device industry
Bachelor's or equivalent university degree in Mathematics, Statistics, Engineering or Science