Process Quality Engineer

Each year, more than 150,000 breast reconstruction procedures are performed in the U.S., yet one in three patients still faces a serious complication. That is not good enough. At Elutia, we are working to change it. Our mission is to humanize medicine so patients can thrive without compromise. We are pioneering drug-eluting technologies to improve the interface between medical devices and the patients who rely on them. How we work matters just as much as what we make. Elutia is a certified Great Place to Work®, grounded in our CRU values: Contagiously Confident, Ridiculously Relentless, and Unanimously United. We set a high bar for ourselves, for each other, and for the outcomes we deliver. Our team is All In on the mission. This is not the place for someone looking to coast. It is the place for someone who wants to solve hard problems, move with urgency, and make a real mark on medicine, alongside a team fully committed to improving patient outcomes. The Opportunity Elutia is seeking a hands-on Process Quality Engineer to drive quality activities supporting the transfer, scale-up, and commercial manufacture of innovative drug-eluting biological products in a small, fast-paced environment. This role will partner closely with Operations and R&D to help translate development processes into robust, controlled, and scalable manufacturing processes. The Process Quality Engineer will support process characterization, design and execute process studies, evaluate manufacturing changes, troubleshoot process issues, and apply sound risk-based Quality judgment to ensure appropriate controls are established and maintained. The role will also support execution and continuous improvement of Quality Management System processes, including change control, nonconformance and deviation management, CAPA, document control, supplier quality, and audits. Key Responsibilities Process Quality Engineering & Scale-Up Partner with Operations and R&D to support development, scale-up, transfer, and implementation of manufacturing processes. Provide Quality Engineering input to process optimization, characterization, scale-up, technology transfer, and commercialization activities. Help identify critical process parameters, sources of variability, and process controls. Contribute to technically sound and appropriately scoped studies to evaluate process variables, equipment, materials, manufacturing changes, and scale-up risks. Support equipment and process qualification and validation, including IQ/OQ/PQ activities. Apply appropriate statistical and risk-based approaches to process characterization, validation, and manufacturing data. Evaluate process performance and variability and identify opportunities to improve process capability, strengthen process control, and reduce manufacturing costs. Provide hands-on Quality support on the manufacturing floor during scale-up, process changes, validation activities, investigations, and troubleshooting. Change Implementation & Problem Solving Lead change controls from technical evaluation through implementation and effectiveness assessment. Lead nonconformance investigations, deviations, CAPAs, and root-cause investigations. Work collaboratively with technical teams to identify effective corrective and preventive actions that address root causes and are appropriate to the level of risk. Apply sound, risk-based Quality judgment to determine the appropriate level of testing, controls, documentation, and escalation. Quality Systems Support Support execution and continuous improvement of Quality Management System processes, including change control, CAPA, nonconformance and deviation management, document control, training, supplier quality, validation, and risk management. Support internal and external audits, including preparation, response development, and follow-up actions. Author, revise, and review procedures, protocols, reports, specifications, and other controlled documents. Help maintain compliant and effective records and training associated with manufacturing and Quality activities. Partner with functional owners to ensure Quality System activities are completed accurately and on time. Contribute to updates of procedures and Quality System processes to support compliant and efficient operations. Qualifications Required Bachelor's degree in engineering, science, or a related technical discipline. 5+ years of Quality Engineering, Process Engineering, Manufacturing Engineering, or closely related experience in medical devices, pharmaceuticals, or another highly regulated field. Demonstrated experience supporting manufacturing process development, scale-up, characterization, or process validation. Experience with change control, investigations, nonconformances, CAPA, and risk management. Working knowledge of FDA Quality System requirements/QMSR and ISO 13485. Strong problem-solving skills and ability to independently drive work to completion in a fast-paced environment with competing priorities. Preferred Experience with combination products, biologic materials, or other complex manufacturing processes. Experience with process characterization, DOE, statistical analysis, and process capability. Experience supporting new-product introduction, manufacturing scale-up, and technology transfer. What Success Looks Like The successful candidate will: Be someone technical teams engage early when developing, scaling, validating, or changing a manufacturing process. Help translate development work into robust, controlled, and scalable manufacturing processes. Independently move Quality and process-related activities from problem identification through resolution. Use strong engineering judgment and risk-based decision-making to determine an appropriate level of testing, controls, and documentation. Keep important Quality System activities moving while simultaneously supporting scale-up and manufacturing priorities. Be comfortable shifting between technical process work and hands-on Quality System execution as business needs require. Produce practical, technically defensible solutions that protect product quality and patient safety while meeting regulatory requirements. Working Style Elutia operates with a small, highly accountable team in a fast-paced environment. This position requires someone who is comfortable being both technical and hands-on, managing competing priorities, and moving work forward with appropriate urgency. Success in this role requires initiative, sound judgment, urgency, collaboration, and a willingness to roll up your sleeves and do what is needed to move the organization forward. Who Thrives Here This place isn't for everyone. At Elutia, we are All In on the mission. This place is built for people who want to compete at a high level, solve hard problems, and do work that matters deeply to patients. The people who thrive here are confident without being arrogant, relentless without being rigid, and team-first to the core. They do not seek comfort, politics, or a carefully managed environment. They want the challenge. They want the ownership. They want to be on a team with other exceptional people and win. This isn't just a job. It is a mission. Priorities shift. Problems hit fast. Constraints are real. We are looking for those who thrive here, rises to the moment, course-corrects unapologetically, and stay locked on the goal line. If someone is looking for comfort, clean boundaries, or a lower-stakes ride, this is the wrong place. If they want to build something meaningful with a team of superstars and leave everything on the field, they will belong here. All in on the mission Confident, not arrogant Calm under pressure and decisive in critical moments Obsessed with outcomes, not status Fast to adapt and hard to rattle Energized by hard problems and high standards More interested in winning championships than MVPs Expected salary range: $75,000-95,000, depending on experience and qualifications. This role is eligible for equity and a performance-based bonus. Elutia also offers a comprehensive benefits package, including medical, dental, vision, life, 401(k) with employer match, and paid time off. Elutia is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. #J-18808-Ljbffr