Quality Specialist

XDemics Corporation, a recently emerged Caltech spinout, has developed a high-density, natural cell culture technology that mimics how cells grow in the human body. By overcoming longstanding oxygen delivery and cell stress limitations, the platform supports healthier and more efficient production of complex therapies including CAR-T, stem cells, and gene therapies, as well as several adjacencies, including cells for biomedical R&D, HTS, biologics, and 3D culture.

We are building a high-performance team to scale operations to support rapid commercial growth.

We are seeking a highly organized and experienced Quality Specialist who thrives in a fast-paced startup environment to help XDemics establish and maintain an ISO 13485 and FDA QSR compliant quality management system supporting the registration and production of our cell culture products as Class I medical devices. The ideal candidate takes ownership, anticipates needs, and solves problems before they escape.

You bring strong attention to detail, clear communication and collaboration skills, and the ability to manage multiple priorities  value professionalism, discretion, and accountability, and you take pride in keeping people, processes, and information running smoothly.

• Support the development, implementation, and maintenance of XDemics’ quality systems to be compliant with ISO 13485, FDA QSR, and other applicable regulations.
• Lead root cause analysis and corrective/preventive actions (CAPA) for product and process non-conformances.
• Handle non-conformances.
• Support design control activities, including risk management (ISO 14971), verification and validation, and design reviews.
• Conduct internal and supplier audits to ensure compliance with quality standards.
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) to ensure quality is built into product development and manufacturing processes.
• Contribute to the creating, review and approval of quality documentation including protocols, reports, Standard Operating Procedures (SOPs) and Work Instructions (WI).
• Execute installation qualifications and operational qualifications.
• Write and execute process and other validations.
• Preform incoming inspections and component qualification studies.
• Perform in process and final inspections.
• Support Document Control.
• Maintain controlled manufacturing areas.
• Monitor and analyze quality metrics to drive continuous improvement initiatives.
• Participate in regulatory inspections and third-party audits.
• Receive, inspect, and verify incoming materials against purchase orders and packing lists.
• Organize and maintain inventory in designated storage locations, ensuring proper labeling and tracking.
• Allocate, stage and deliver materials to production lines according to work orders and schedules.
• Scrap handling
• Collaborate with EH&S to maintain a safe workplace

• High school diploma or GED
• 5+ years of experience working in general manufacturing, medical device experience a plus
• Written communication skills to complete reports
• Attentiveness to detail to spot flaws in products or problems with equipment
• Problem-solving abilities to troubleshoot
• Ability to move materials or finished goods from one location to another
• Time management skills to produce the required number of parts or products each shift

• Competitive salary and elite benefits package.
• Opportunity to work in a fast-paced, innovative environment with a team of dedicated professionals.
• Career growth and development opportunities within a rapidly expanding company.
• Access to state-of-the-art facilities and resources.

XDemics is an equal opportunity employer and is committed to creating an inclusive environment for all employees.

We offer our employees competitive compensation and elite benefits, including paid time off, health, vision and dental insurance, disability insurance, flexible spending accounts, a 401(k) plan (plus match), and participation in the company’s stock option plan.