Robert Conley

I’m a Quality and Regulatory Engineer focused on medical device compliance, from design review through validation and manufacturing oversight. I lead quality activities for Class I & II medical devices, including implantable device accessories, and I’m known for turning audits, requirements, and data into actionable process control.

I oversee sterilization data and annual revalidation protocols (steam and EtO), manage Class 7 & 8 clean room testing and certifications, and coordinate critical facility changes based on scan test results. I also drive supplier audits and maintain supplier performance programs, while supervising quality teams and strengthening inspection and auditing readiness through training and interviews for new hires.

Earlier, I served as a Quality & Regulatory Engineer/Manager, building quality systems using ICH-aligned approaches for FDA compliance and partnering with R&D and external GLP labs to support biological evaluation and stability claims. I’ve also maintained quality systems to ISO9001 requirements, supported CAPA, MRB, calibration and corrective action workflows, and supported CE marking work—bringing disciplined quality governance and continuous improvement to every stage of product development and manufacturing.