Represent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy
Job Summary
Represent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy.
Provide expert guidance to Quality Engineers, Technicians, and Inspectors, and develop comprehensive test protocols and final reports that support critical regulatory submissions.
Collaborate with our R&D teams to support Pre-Concept Front End Product Innovation Process activities, helping bring groundbreaking technologies to life.
Matching Summary
Represent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy.
Skills & Requirements
Must-have
Design Control Documentation
Risk Management
Design Verification & Validation
Test Method Development
CAPA Implementation
Statistical Analysis
Nice-to-have
Collaboration and Innovation
Human Element Focus
Continuous Improvement Culture
Key Requirements
Bachelor Degree in Engineering or Technical Sciences and 2 years experience OR Masters' Degree and 1 year experience
Experience in Quality Engineering or related discipline
Experience with design controls, product/process validation, risk management, and technical problem solving
Knowledge of FDA QSR, ISO13485, ISO14971, and ISO 9001
Minimum 4 days of in-office presence per week required