Job Title: Quality Engineer
To assist the Quality Operations Manager in implementing a Quality Management System and supporting the overall quality team.
Key Responsibilities:
* Monitor production and release of finished parts to ensure adherence to quality policies and procedures.
* Interface with customers to achieve satisfaction.
* Investigate root causes and implement corrective actions for customer and internal quality issues.
* Initiate and complete CAPA, engineering change requests, and non-conformance reports as required.
* Establish and monitor inspection standards, plans, frequencies, and test methods.
* Develop and maintain FMEAs and quality system documentation.
* SUPPORT CUSTOMER AND SURVEILLANCE ACCREDITATION AUDITS.
* Contribute to quality planning and new product introduction from a quality perspective.
* Maintain knowledge of quality management systems (ideally ISO13485) and other product-related regulatory requirements.
* Build relationships with customer organizations and project stakeholders.
* Advantageous to have validation experience.
* Continuously improve the quality management system.
* Support operations area projects and initiatives.
* Train personnel on quality procedures and documentation.
* Ensure proper storage and handling of samples and quality records.