QA Engineer, Manufacturing

Drive improvements to the quality system that ensures its suitability, adequacy and effectiveness. Provide operational support related to issue resolution, product quality/risk assessment and product disposition. Lead implementation of quality system processes which may include but are not limited to complaint handling, document control, corrective and preventative action, non-conforming material and deviations. Provide facility quality support and representation in new product development, scale up, design transfer, and facility validation activities. Represent quality on core design change and new product development teams to ensure the design control process is being followed effectively and to create deliverables including batch records and control plans. Provide support in customer, supplier and regulatory audits. Generate and provide quality metrics for management review. Approve process changes as defined by Quality system. Approve the release of product for shipment to customer. Release new product development projects to Operations for production.

Experience:
3 years relevant experience in Quality preferred. Knowledge of ISO 13485 and 21 CFR Part 820 preferred. Six Sigma Training a plus.