Quality Assurance Engineer

Under the guidance of the Quality Manager and other Engineers, the Quality Assurance Engineer I shall support the facility and departments in the development, implementation and maintenance of the quality system. This includes supporting both the quality and manufacturing departments with regards to the applicable QSRs and ISO standards.

Principal Responsibilities

1. Assists in continuous improvement initiatives focused on enhancing product quality and reliability.
2. Assists in ensuring the manufacturing processes comply with regulatory and quality system standards, including FDA, ISO 13485, and other relevant industry regulations.
3. Assists to Develop, implement, and maintain process control plans and standard operating procedures (SOPs) to ensure consistent product quality throughout production.
4. Collaborate with cross-functional teams, including engineering, supply chain, and production, to identify and resolve...