Quality Assurance Specialist
We are seeking a motivated Quality professional who thrives in regulated, innovative environments.
* Collaborate with R&D and Process Engineering teams to support product development, process improvements, and transfers.
* Promote compliance and excellence to meet customer requirements and regulatory standards (FDA, ISO 13485, MDR).
* Lead equipment, process, and product validations aligning with quality and regulatory expectations.
* Conduct root cause analysis, manage non-conformances, and implement CAPAs for continuous improvement.
* Support internal and supplier audits, ensuring findings are addressed and preventive actions are in place.
* Manage and investigate customer complaints, performing failure mode analysis and implementing quality improvements.
* Provide day-to-day Quality support for manufacturing operations, ensuring product integrity.
A degree in Engineering or Quality Assurance is required, along with at least 3 years of experience in a Quality role within a cleanroom or regulated manufacturing environment.
Benefits Include:
* Collaborative Team Environment
* Opportunities for Professional Growth and Development
* Competitive Compensation Package
* Comprehensive Benefits Program