Teams at Biolinq Incorporated

Reviews Device History Records, performs product and labeling inspections, leads production line audits, supports audit readiness, documents quality metrics, resolves discrepancies, and drives corrective actions and continuous improvement. The role ensures compliance with SOPs, ISO 13485, 21 CFR Part 820, and evolving quality-system requirements in a regulated medical-device clean-room production environment.

Manages quality document control activities, including change orders, training assignments, document and device history record numbering, logbooks, manufacturing records, and quality procedures. Supports NCMR and CAPA investigations, supplier management, departmental reporting, employee training, onboarding, and internal or external audits. Collaborates with engineering, manufacturing, quality, and other cross-functional teams in a regulated medical device environment.

Oversee daily manufacturing operations, production scheduling, staffing, training, safety, quality, delivery, and cost performance. Supervise and develop a multi-shift team, troubleshoot production issues, maintain GMP/GDP compliance, manage materials and inventory, analyze manufacturing data, support documentation and testing, and drive process efficiency and continuous improvement in a cleanroom environment.