Susan Mathison

About Susan Mathison

Engineering and Quality Assurance leader with experience in Product Development, Project Management, and Quality Assurance / Quality Control. I help small to mid-size biotech organizations comply with regulations and accelerate product launch timelines, beginning with defining business strategy and market scope, then tailoring the Quality Management System to the company\'s needs and creating regulatory strategies that get products into surgeon\'s hands faster. I have established Design Control (21 CFR 820.30) and Risk Management programs for 3 organizations varying in size from start-up to multi-site global organization. Procedures are custom to the company size/culture and flexible regarding the product/process.I have developed regulatory strategies that allow for rapid commercialization incorporating direct input from FDA. For one company, I reduced a project timeline by 6 months and cut development costs by $300k.I am passionate about continuous improvement. I target process risks and negative trends, then lead cross-functional teams to identify root causes and take necessary action. I collaborated on the establishment of in-house endotoxin assays and development of a packaging process, resulting in a savings of 9 weeks and $5k per batch produced.

Experience

1. Manager, Quality Engineering

   Intuitive

   Nov 2024 — Present · Chapel Hill, NC, US

   Head of Quality for the Advanced Tissue Models, Chapel Hill facility. Develops and executes short and long term quality strategies necessary to support operations.Leads group of Quality Engineers and Technicians, supporting them in achieving their goals and day-to-day responsibilities.Establishes metrics and guidelines to functions to assist in trending and improving product quality.Ensures that all operations performed in the Advanced Tissue Models, Chapel Hill facility comply with quality management system and procedures.Supports new product introductions, escalations, CAPAs, and audits.Fosters Six Sigma and continuous improvement.Liasons with other Quality leaders, as it applies.

Education

• University of Tennessee, Knoxville

  Bachelor of Science (B.S.), Engineering Science and Mechanics; Concentration: Biomedical Engineering

• University of Florida

  Master of Science - MS, Biomedical Engineering