Quality Assurance Engineer Role Overview
We are seeking a seasoned quality assurance engineer to join our team and contribute their expertise in ensuring the highest standards of quality in medical devices.
Main Responsibilities:
* Develop and implement robust inspection methods and sampling plans for high-volume components, ensuring accuracy and repeatability.
* Collaborate with cross-functional teams, including R&D, Supplier Quality, and Operations Engineering, to drive quality processes forward.
* Design, develop, and qualify custom inspection fixtures and measurement equipment to meet industry standards.
* Conduct Gage R&R studies and measurement system analyses to identify areas for improvement.
* Develop and validate test methods to ensure compliance with regulatory requirements.
* Analyze and resolve Out-of-Spec events, driving root cause analysis and corrective action activities.
* Provide training and supervision to lab personnel on inspection techniques and quality standards.
* Manage documentation, including Change Orders and Non-Conformance Material Reports, to ensure traceability and audit readiness.
About the Job:
This is an excellent opportunity for a motivated and detail-oriented quality assurance engineer to make a meaningful impact in the medical device sector. If you have a passion for improving human health through high-quality engineering solutions, we encourage you to apply.