Judy Andrews

Director / Partner


Over 20 years’ experience in the Medical Devices and Pharmaceutical industries with extensive quality systems knowledge and skill in quality operations management specifically in fast-paced high-risk environments. An experienced auditor across multiple disciplines incorporating and implementing risk at all stages of a process.  

Judy’s professional experience has led her to work directly with clients, partners, the C-suite, and regulators to commercialise and register new products or make changes to registered products. She is an excellent communicator and is at ease working with operators on the shop floor as well as at the board level.  

Her previous experience includes over 10 years in the medical device industry as Head of Business Operations and Compliance. Responsibilities included quality control and quality assurance, regulatory and clinical affairs, HS&E, engineering, manufacturing, supply chain and operational excellence. During that time products designed, developed, and commercialised included a precision handheld blood glucose analyser and a handheld blood coagulation analyser that rivalled the precision of equivalent laboratory analysers. Both products remain a commercial success.     

Judy’s experience also includes 10 years in the pharmaceutical industry as a production lead and an HS&E and Quality and Regulatory Auditor at CSL Ltd (now Seqirus) in Parkville, Australia. Her area of expertise being sterile vaccine manufacture, facility compliance auditing and risk management.  

Areas of Expertise

  • Regulatory Compliance FDA TGA ISO 9001 and 13485
  • Lead Auditor and experienced audit host
  • ISO 14971 Risk Management
  • IEC 62304 specialist
  • Hazard Analysis and Critical Control Point 
  • Computerised System Validation (CSV)
  • Quality Control
  • Stability and Clinical Studies
  • Operations and Supply Chain
  • Lean Six Sigma process mapping and optimisation
  • Design and development lifecycle