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 cleanrooms, 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 Files (ISO 14971) for diverse product lines with varying regulatory pathways; author risk control packages and drive timely implementation of mitigations from design through post-market surveillance Support global registrations, inspections, and surveillance audits; compile objective evidence, facilitate on-site interactions, and drive timely response to findings Assist in maintaining and enhancing the QMS to ensure efficient compliance with ISO 13485, MDR 2017/745, FDA: 21 CFR Part 820 and other applicable regulations Create training programs for manufacturing personnel; ensure employees are trained to perform their work and that their training is documented Support GLP and GCP activities when manufacturing provides test articles or clinical supplies Identify opportunities to optimize quality processes and reduce regulatory burden while maintaining compliance. Lead continuous improvement initiatives to reduce cycle times and eliminate redundancies Establish and track manufacturing KPIs, yield improvements, and cost reduction initiatives for management reviews Key qualifications: Engineering Degree or equivalent in quality, regulatory and/or life sciences Minimum 3 years of progressive GMP experience in medical device and/or biologics manufacturing Strong understanding of FDA 21 CFR 820, 211, 1271 and EU GMP guidelines Experience with wafer production and medical device assembly manufacturing processes (e.g. batch release) Experience with process validation (IQ/OQ/PQ) for both equipment and manufacturing processes Knowledge of cell culture, aseptic processing, and biological manufacturing controls Proven project management skills with ability to drive regulatory submissions Excellent communication skills with ability to work across diverse technical teams Strong problem-solving capabilities and attention to detail Demonstrated success managing parallel projects in a fast-paced environment, balancing compliance rigor with agile execution to meet aggressive timelines Detail-oriented with strong organizational and problem-solving skills Ability to interpret standards and regulations into actionable requirements and documentation needs across varied technologies Ability to travel (domestic and international; to various company locations and third-party sites). Preferred qualifications: Experience with implantable medical devices, Class II-III medical devices, biologics, or combination products Demonstrated expertise in cleanroom design and operations (ISO 14644) Knowledge of Good Tissue Practices (21 CFR 1271) and cellular therapy manufacturing Strong knowledge of global medical device regulations, particularly MDR 2017/745, 21 CFR Part 820, Good Manufacturing Practices, ISO 9001, ISO 13485, ISO 14971, ISO 62366 Trained in internal and supplier audits Experience with regulatory inspections and audit management (e.g. FDA, Notified Body) Knowledge of multiple medical device regulation areas Experience managing quality and regulatory activities across multiple product lines simultaneously Working knowledge across multiple GxP disciplines (GLP, GCP) with ability to provide cross-functional support and adapt to different regulatory environments as business needs require Proficiency with electronic QMS, PLM, CMMS, and project-management tools (e.g., Asana) Science is required under California law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on the indicated salary band. The base salary range for this full-time position is $115,000-$175,000 annually + equity + benefits. Within the range, individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers. Benefits: At Science, our benefits are in place to support the whole you: Competitive salary and equity Medical, dental, vision and life insurance Flexible vacation and company-paid holidays Healthy meals and snacks provided for non-remote employees Paid parental, jury duty, bereavement, family care and medical leave Dependent Care Flexible Spending Account, subsidized by Science Flexible Spending Account 401(k) Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local laws. #J-18808-Ljbffr