Senior Quality Engineer l Medical Device Manufacturing

• Support the launch and ongoing manufacturing of medical devices by identifying, qualifying, and partnering with primarily domestic contract manufacturing suppliers to ensure quality, delivery, and performance objectives are achieved.
• Provide production support for existing product lines through supplier selection, supplier relationship management, and execution of corrective and preventive actions (CAPA).
• Collaborate with Product Development teams to provide quality and manufacturing expertise throughout the product development lifecycle while ensuring compliance with Design Control requirements.
• Contribute to product designs by supporting Design for Reliability (DFR), Design for Manufacturability (DFM), Design for Inspection (DFI), regulatory compliance, and cost optimization initiatives.
• Lead root cause investigations related to manufacturing issues, nonconformances, customer complaints, and field feedback, implementing effective corrective actions to prevent recurrence.
• Develop, coordinate, and execute process validation and production qualification activities to ensure manufacturing processes consistently meet quality and regulatory standards.
• Support strategic manufacturing initiatives, including the evaluation and implementation of new internal manufacturing capabilities and the potential transition of outsourced processes to in-house production.
• Design and execute testing protocols, validation studies, and product evaluations to verify functionality and demonstrate compliance with applicable regulatory and quality requirements.
• Prepare, maintain, and manage Design Control documentation, including design history files, risk management documentation, validation records, and other product development deliverables.
• Work cross-functionally with Engineering, Quality, Regulatory Affairs, Operations, and Supply Chain teams to drive product quality, process improvement, and operational excellence.
• Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and internal quality management system procedures.
• Support continuous improvement initiatives focused on product quality, supplier performance, manufacturing efficiency, and customer satisfaction.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.