Let's Combinate - Drugs + Devices with Subhi Saadeh

On this episode we had Cameron Jones PhD, Co-Founder and CEO at Avasys. Cameron holds a PhD from University of Kentucky and did Post-Doctoral work at John’s Hopkins University. He has a passion for innovation and trying to find and address unmet clinical needs by working with the clinicians to craft fit for purpose solutions. In this episode we discuss the relationship between academia and innovation, how he pursued industry in graduate school, his upbringing, compassion and his zest for life. Cameron can be reached at http://www.avasysmedical.com/services/.

I’m truly happy I discovered Andy Robertson before I took my own CQE exam. His tools, lessons and strategies were crucial in passing the exam on my first try. His passion and love for quality engineering jumped out and after becoming more familiar with his content and style, I thought “I have to meet this guy”. On this episode we discuss study habits, mastery, learning styles, applying CQE principles, and caring as a pillar of leadership.

Andy Robertson is a CQE’s CQE. Andy is a career engineer and learner who worked in the medical device industry in various roles in R&D, Operations and QA. He has spent the last decade teaching and mentoring his students to pass the CQE exam and recently moved to drive CQE Academy full time. Andy can be reached at cqeacademy.com and has a YouTube channel as well.

Hope you enjoy and as always, if you’d like to help the show, feel free to share.

#quality #qa #medicaldevice #leadership

In this episode I sit down with Mark Swanson.

We discuss Mark’s background and early career, his entrance into QA, his participation on standard work groups for ISO13485 and ISO9001, the standards process and more.

Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and a Principal Consultant of Quality and Regulatory Expert Partners (QRx Partners); a partnership consulting firm focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all quality roles. He is a senior member of ASQ, corporate AAMI member (serving on several AAMI committees) and a RAPS member.

Mark has spent several years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) that published the revision of ISO 13485 in 2016 and was the project co-lead for the guidebook on ISO 13485. Mark is the chair of AAMI mirror committee for WG6 on post-market surveillance, member of the US mirror committee for JWG1 for ISO 14971/TR 24971 and has also participated with ISO TC176, on ISO 9000:2015 & ISO 9001:2015 as well as IWA31 on the application of risk management. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.

Excited to drop episode 002- “Seeing David in the Stone: Predictive Quality Management” with Larry Mager from Mgmt-Ctrl. I hope you enjoy this episode!

Apple Podcasts: https://tinyurl.com/7y9k5kj8

Spotify: https://tinyurl.com/3w5chwhf

Larry and I discuss a lot in this episode, most notably what Predictive Quality Management is and how “Quality is Free”.

Larry Mager is the author of the books “The Quality Journey” and “Management Control Quality plan”. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement.

You can reach Larry at [email protected]

#qualityassurance #quality #leanmanufacturing #medicaldevice #riskmanagement

I wanted the first episode to be very special so I invited someone who was instrumental in my development as an engineer and a person. I’d like to introduce you to Episode 001 - “Learning Never Exhausts the Mind” with Rick Doe! https://www.linkedin.com/in/rick-doe-aa312330