Teams at Biolinq Incorporated

Leads clinical study execution, monitoring, site training, compliance follow-up, regulatory documentation, and trial master file maintenance. Serves as a primary contact for clinical sites, conducts monitoring visits, prepares reports and study materials, supports audits, and mentors junior team members. The role requires frequent travel to clinical sites, medical facilities, and laboratories, with responsibility for maintaining Good Clinical Practice and HIPAA compliance.

Designs, develops, qualifies, deploys, and sustains automated manufacturing equipment and fixtures for medical device production. Leads automation projects through requirements, design, vendor management, FAT/SAT, validation, deployment, and sustaining support. Improves quality, capacity, repeatability, and cost through process automation, statistical analysis, root cause investigations, and equipment optimization. Partners with R&D, Manufacturing Engineering, Quality, Validation, and external suppliers to scale processes into commercial production.

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.