Job Overview
As a Quality Assurance Specialist, you will play a critical role in ensuring the smooth operation of our sites quality management system. You will work closely with R&D and Process Engineering teams to support product development, transfers, and process improvements.
* Collaborate with cross-functional teams to drive product excellence, customer satisfaction, and regulatory compliance.
* Promote a culture of quality and excellence, aligning with industry standards (FDA, ISO 13485, MDR).
* Lead equipment, process, and product validations to meet quality and regulatory expectations.
* Conduct root cause analysis, manage non-conformances, and implement effective corrective actions to drive continuous improvement.
* Support internal and supplier audits, ensuring findings are addressed and preventive actions are in place.
* Investigate customer complaints, performing failure mode analysis and implementing quality improvements.
* Provide day-to-day quality support for manufacturing operations, ensuring product and process integrity.
About This Role
This is an exciting opportunity for a detail-oriented professional who thrives in a fast-paced environment. As a Quality Assurance Specialist, you will be responsible for maintaining and improving our quality management system, ensuring seamless product transitions, and promoting regulatory compliance.