214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)

214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)

In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how it boosted his confidence and expertise in quality engineering. They explore the practical applications of Design of Experiments (DOE), including a real-life example where Andy applied DOE concepts at work. Andy also discusses the value of various ASQ certifications, including CQE, CQA, CQM/OE and Six Sigma Green Belt, emphasizing their importance for career growth.

The conversation extends to non-ASQ certifications such as PMP, highlighting their relevance for leadership roles. By comparing practices from various industries, including automotive and medical devices, they underscore the importance of cross-industry learning. Andy concludes by inviting listeners to join his courses to further their own professional development.


00:00 Welcome and Introduction

00:48 The Impact of CQE Certification

02:23 Applying DOE in Quality Engineering

05:42 Top ASQ Certifications

13:35 Non-ASQ Certifications and Leadership

15:55 Cross-Industry Learnings

18:45 Conclusion and Contact Information


Andy Robertson is the founder of CQE Academy and a leading educator in the quality profession. With a background in medical devices and years of hands-on experience as a quality engineer, he built a global audience through his practical, passionate approach to teaching CQE, Green Belt, and quality systems fundamentals. Andy’s work centers on helping professionals gain confidence, accelerate their careers, and master the core tools of quality through clear, accessible education.


Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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Jaksot(245)

231 - Audit Findings Explained: Nonconformity vs Observation (CQA)

231 - Audit Findings Explained: Nonconformity vs Observation (CQA)

This is a lesson out of my ASQ CQA course with Andy Robertson, on how to write and classify audit findings.Access the full CQA course here: https://cqeacademy.teachable.com/p/the-cqa-master-class-cour...

25 Maalis 11min

230 - How Pharma Misses Critical Market Signals with Joe Luminiello

230 - How Pharma Misses Critical Market Signals with Joe Luminiello

In this episode of Let’s ComBinate, Subhi Saadeh sits down with Joseph Luminiello, CEO and Co-Founder of RCG Intel, to break down how competitive intelligence is actually used in biopharma and why mos...

23 Maalis 30min

229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products

229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products

In this episode of Let’s Combinate, Subhi Saadeh speaks with Jen Riter about analytical method validation for drug device combination products. The discussion explores how traditional drug analytical ...

11 Maalis 31min

228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently

228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently

Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in li...

4 Maalis 6min

227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics

227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics

Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.Times...

24 Helmi 28min

226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification

226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification

In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance un...

18 Helmi 29min

226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions

226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions

In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 fr...

11 Helmi 8min

225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes

225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes

In this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substan...

4 Helmi 9min

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