We are seeking a Quality Engineer I – Disposables to support the Quality Management System (QMS) and ensure the quality and compliance of electronic components and medical devices throughout their lifecycle. This role provides hands-on support for manufacturing, investigations, and quality processes while developing foundational skills in validation, risk management, and problem-solving.
The QE I works closely with cross-functional teams including Manufacturing, Engineering, R&D, Regulatory, and Supply Chain to support product quality and continuous improvement initiatives in a regulated environment.
What You’ll Do
- Support investigations for nonconformances, complaints, and CAPAs, including data collection and root cause analysis
- Assist in executing CAPA activities and tracking to closure
- Provide day-to-day quality engineering support to manufacturing operations
- Support validation activities (IQ/OQ/PQ), test methods, and equipment qualifications
- Assist in developing and updating risk management documentation (FMEAs, risk assessments)
- Review production and quality data to identify trends and improvement opportunities
- Support supplier quality activities, including monitoring performance and corrective actions
- Assist in reviewing engineering changes, procedures, and quality records
- Contribute to continuous improvement and waste reduction initiatives
- Collaborate with cross-functional teams to ensure compliance with internal and regulatory requirements
For additional details and the most recent updates, hit “Apply for job”
