247 - Why Everyone in Pharma and MedTech Should Work in Quality

Let's Combinate · 22 Jul 2026 · 8m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate, argues that quality roles in MedTech and Biotech provide a broader business understanding than other functions. He explains that quality professionals learn to make defensible, risk-based decisions in gray areas and develop the ability to influence outcomes without direct authority. Saadeh emphasizes that this experience builds judgment and systems thinking, making it a valuable career path for anyone in the industry.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 50m

    #352: Fundamentals of Quality & Regulatory

    Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former quality leader at Medtronic, Boston Scientific, and Johnson & Johnson, discusses the strategic role of quality and regulatory professionals in the medical device industry. She emphasizes that effective quality management requires strong project management skills, proactive stakeholder influence, and a deep understanding of human factors to prevent post-market failures. Mascioli-Tudor also advocates for building a culture of psychological safety and continuous improvement, arguing that quality teams must act as business partners rather than just compliance police.

  • Global Medical Device Podcast · 50m

    #440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory

    Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former VP of Quality at Medtronic and Boston Scientific, discusses the evolution of quality and regulatory roles in the medical device industry. She emphasizes that quality professionals must act as strategic influencers and project managers, using storytelling to connect compliance requirements with business outcomes like cost of poor quality. The conversation covers the importance of human factors in design, the nuanced concept of 'design freeze', and the necessity of proactive quality management to ensure patient safety and regulatory agility.

  • Global Medical Device Podcast · 26m

    #452: Switching Careers to MedTech: A Practical Guide for Engineers and Professionals

    Etienne Nichols, a former aerospace engineer turned MedTech professional, explains how engineers and quality professionals from automotive, aerospace, and manufacturing can transition into the medical device industry. He outlines three primary entry points—Quality, Regulatory Affairs, and Product Development—and emphasizes that while technical skills like root cause analysis and project management transfer well, the mindset must shift from 'move fast and break things' to rigorous documentation and risk management. Nichols provides a five-step roadmap for career switchers, including learning regulatory language, obtaining targeted certifications, and networking with intention, before concluding that long-term career growth requires mastering the 'layer above competence': communication, visibility, and storytelling.

  • Global Medical Device Podcast · 44m

    #354: Advice for MedTech Regulatory Affairs Professionals

    Kavetha Ram, Regulatory Department Leader at Spectra Medical Devices and professor at Northeastern University, advises new regulatory affairs professionals on navigating the MedTech industry. She emphasizes that confidence stems from understanding one's unique background and the value of diverse perspectives in cross-functional teams. Ram highlights the importance of bridging the gap between academic theory and real-world regulatory changes, such as the EU MDR, through active networking and continuous learning.

  • Global Medical Device Podcast · 53m

    #421: Mastering MedTech Influence: The Power of Communication in Quality

    Lesley Worthington, an executive coach with a background in psychology, law, and quality/regulatory affairs, discusses how quality professionals can build influence and a culture of quality through better communication. She argues that technical correctness often fails to drive buy-in because it ignores the listener's need to feel understood, advocating for active listening, paraphrasing, and plain language over jargon. Worthington highlights the limitations of traditional corporate training, which focuses on information rather than habit change, and suggests that personalized coaching or reflective writing (like 'morning pages') helps professionals overcome burnout and imposter syndrome by clarifying their thinking and building psychological safety.

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