Teams at Evergen (evergenbio.com)

Supervises daily Quality Control operations in a regulated regenerative medicine manufacturing environment. Oversees inspections, reviews, product release, staffing, training, performance metrics, investigations, root-cause analysis, CAPA implementation, audit readiness, and continuous process improvement. Collaborates with Manufacturing, Quality Assurance, Engineering, Logistics, and other stakeholders to improve quality-system throughput and operational performance.

Leads quality engineering for medical device design and manufacturing projects, including risk management, CAPA, complaint handling, investigations, process validation, reliability engineering, and quality system optimization. Represents the company during FDA, notified body, and supplier audits, drives remediation, mentors quality engineers, and partners with senior leadership on quality strategy. The role requires advanced regulatory, statistical, and quality management expertise and includes up to 25% international travel.

Leads end-to-end CDMO project management for regenerative medicine and medical device programs, including plans, schedules, budgets, resources, risks, KPIs, stakeholder communication, client proposals, design transfer, pre-validation manufacturing, and regulatory compliance. Partners with commercial and global cross-functional teams, supports process scale-up and manufacturing improvements, prepares technical documentation, and maintains client relationships. This is a six-month, 100% onsite contract with potential conversion.