Quality and Regulatory GMP Engineer

Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience’s hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

The QARA GMP Engineer will serve as the manufacturing and production expert within our Quality and Regulatory Affairs team, where each team member brings both quality and regulatory knowledge but specializes in a specific domain. This unique role requires knowledge spanning traditional medical device manufacturing and biologics production to support our innovative product lines. While production focused, this position requires the ability to flex into other GxP activities as needed, drive regulatory submissions, lead complex projects from concept through commercialization, and assist in evolving and maintaining the Quality Management System (QMS).

This position blends quality, regulatory, and project management expertise with agile methodologies to accelerate time-to-market while safeguarding patient safety and regulatory compliance.

Role responsibilities:

• Lead cross-functional project teams to drive regulatory milestones, accelerate product development timelines, and ensure timely product launches while maintaining compliance standards
• Champion a flexible, risk-based approach to Quality and Regulatory compliance, coordinating sprint planning, backlog prioritization, and cross-functional meetings to keep projects on schedule.
• Drive manufacturing sections of regulatory submissions (DMR, manufacturing process descriptions, facility information)
• Interface with FDA and other regulatory bodies on GMP inspection readiness and responses
• Collaborate in establishing and optimizing Good Manufacturing Practices (GMP) environments for diverse production needs (e.g. ISO Class 5-7 clean rooms, cell culture processing facilities, and protein engineering), including establishment of environmental monitoring programs and contamination control strategies; implement Good Tissue Practices (GTP) where applicable
• Establish quality agreements with contract manufacturers handling specialized processes as needed
• Design and validate manufacturing processes for Class II-III medical devices and biologics, including validation of cleaning, sterilization, and bioburden control procedures
• Manage multiple manufacturing projects across different product lines and technologies
• Lead technology transfer from R&D to manufacturing, with an eye for scalability, guiding staff on design for manufacturing principles
• Coordinate design reviews, verification/validation testing, and change-control justifications; ensure critical parameters are documented, justified, and tested prior to implementation
• Serve as quality representative on material review board
• Manage equipment calibration, qualification, and preventive maintenance schedules. Troubleshoot equipment issues and coordinate repairs with vendors
• Conduct product release inspections, managing quality control processes, and collaborating with production teams
• Perform inspection and testing of purchased materials, components and products in accordance with policy and procedures
• Contribute to materiovigilance activities, field corrective actions, and recall readiness.
• Work cross-functionally to identify, root cause, and resolve quality issues (e.g. nonconforming product); implement corrective and preventative actions
• Own supplier qualification for specialized materials including biological reagents, cell culture components, and semiconductor-grade materials
• Prepare and review regulatory submissions (Technical Files, UKCA dossiers, PMA/Supplements, IDE, 510(k)) across multiple product portfolios simultaneously; interface with notified bodies and regulators to address questions and obtain clearances/approvals
• Own creation and maintenance of comprehensive Risk Management…