Rick Holecek walked into a quality nightmare: 27 open CAPAs from a botched audit report, a semi-paper-based system struggling to keep up with growth, and a small team stretched impossibly thin. As VP of Quality at Irrimax, a wound irrigation company that's grown from 30 to 76 employees in six years, Rick had to make fast decisions that would either save or sink the company's regulatory standing. 

In this episode, Rick shares the intense triage process that separated legitimate findings from recommendations disguised as audit failures, the lightning-fast implementation of a full electronic quality management system in just weeks, and the leadership philosophy that tears down walls between engineering and quality. Plus, Rick offers his vision for AI-powered predictive quality systems and why the old "quality as police" model is dead.

Timestamps: 

[00:00] Welcome and introduction to Irrimax 

[02:10] Current regulatory priorities and QMSR migration 

[03:00] The 27 CAPA crisis: what went wrong 

[05:30] Triaging and closing unnecessary CAPAs 

[06:30] Pivoting from paper to electronic QMS in weeks 

[08:00] Exploring AI-powered quality management systems 

[12:00] The magic wand: predictive AI for quality 

[13:20] Breaking down walls between engineering and quality 

[15:00] Building a quality culture from day one 

[17:00] A collaboration story that changed everything 

[20:00] Rapid fire: challenges, resources, and superpowers 

[23:40] What MedTech teams should stop doing today

Follow Melita and Rick: 

Connect with Melita: 

LinkedIn: https://www.linkedin.com/in/rick-holecek-04b51b12/

Website: https://www.mbcaconsulting.com/about-us

Connect with Rick: 

LinkedIn: https://www.linkedin.com/in/rick-holecek-04b51b12/

Website: https://www.irrisept.com/about/