Chelsae O’Halloran has over 10 years of experience in Quality Systems, Quality Engineering and Design Assurance. She has worked in various environments, including pre-clinical and early-stage commercial startups, a fortune 500 company, and a mid-size contract R&D and manufacturing company. Her varied Quality experience also includes support for Regulatory Affairs deliverables, including a variety of Class I, II and III medical devices and drug delivery devices.

Chelsae’s achievements include the following:

Quality Systems

  • Led various programs through EU MDR transition;
  • Executed complaint investigation and managed MDR and vigilance reports;
  • Carried out several CAPA investigations and managed the CAPA review board;
  • Managed the internal audit program and executed various internal audits;
  • Supported various notified body and client audits;
  • Completed Design History File audits for products at various stages of development and manufacturing;
  • Developed and improved various QMS process elements including, but not limited to Design Control, Risk Management, CAPA, Complaint Investigation, Nonconforming Material and Supplier Management while right-sizing approaches based on client’s size and needs; and,
  • Played key roles in FDA audits resulting in zero 483 findings.

Design Assurance

  • Designed and validated test methods for mechanical and electromechanical systems;
  • Created complex bench studies and master verification plans for streamlined execution using risk-based sample size selection;
  • Developed requirements documentation for drug delivery devices and implantable medical devices;
  • Drafted risk management documentation utilizing tools such as Hazards Analysis, Fault Tree Analysis, Use, Design and Process FMEAs, and maintained documents through various stages of development through production;
  • Created post-market surveillance reports for evaluating updates to existing risk management post-production; and,
  • Developed and carried out remediation strategies for several legacy devices, balancing industry standard experience with risk in both the US and EU.

Quality Engineering

  • Investigated several nonconformance reports and managed nonconformance review board;
  • Created inspection sampling plans and oversaw QC inspection; and,
  • Developed Master Process Validation Plan and protocols for manufacturing of mechanical devices.

Chelsae holds a B.S. in Biomedical Engineering and a B.A. in Spanish from the University of Rhode Island.