2026-October ASQ Orange Empire, Section 0701, Monthly Meeting- Oct. 13th

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Storyline

Products fail primarily because of organizational disconnects rather than technical shortcomings. Quality creates its greatest value when embedded early in development and used to guide risk-based decisions. Cross-functional alignment, effective governance, and leadership enable successful commercialization.

Central Message

The organizations that consistently launch successful products build quality into development through collaboration, risk management, and organizational alignment rather than relying on inspection and compliance alone.

Talk will cover how customer needs are translated into product requirements, designs, manufacturing processes, and commercial products, and why successful development depends on effective collaboration among R&D, Quality, Regulatory, Operations, Supply Chain, Marketing, and Leadership. The discussion reframes quality as a strategic business capability that reduces uncertainty and enables better decisions through risk management, design controls, and Stage-Gate governance. Participants will leave with practical insights for improving cross-functional alignment, preventing problems before they occur, and driving successful product launches.

Key Audience Takeaways

• Quality must be built in, not inspected in.
• Product success is a cross-functional responsibility.
• Stage-Gate governance enables better decisions, not bureaucracy.
• Quality and R&D create maximum value when acting as strategic business partners.

Sreeram Balasubramanian grew up in Chennai in India. He did his Bachelors, Masters and Ph.D in Ceramic Engineering. He started his career as a Research Scientist developing ceramics for Defense and Aerospace applications at Surmet Corporation in NY where he got his first introduction to Quality Control as a member of the Internal Audit team. He then transitioned to Glidewell Laboratories in Irvine, a medical device company and the leading Dental lab, where he currently works as a Senior Director of R&D.

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Strong Quality systems are necessary—but procedures alone do not prevent Quality failures.

Through real-world scenarios and interactive discussion, we’ll look beyond procedures and retraining to explore how communication, trust, competing priorities, and ownership affect CAPA, audit readiness, change, and continuous improvement.

Attendees will leave with practical questions they can use to better understand problems, strengthen Quality culture, and build shared ownership. As AI changes how we work, human judgment and accountability matter more than ever.

Vaishnavi (Vee) is a Quality leader with 15+ years of experience across the medical device, diagnostics, and pharmaceutical industries. Her career has evolved from quality engineering and new product development to QMS, risk management, and Quality leadership. Her experience spans CAPA, validation, audit readiness, and organizational change, with a strong focus on cross-functional and supplier collaboration.

Her leadership philosophy is, “Seek to understand before seeking to change.” She believes sustainable Quality starts with strong systems—but succeeds through people, communication, trust, and shared ownership. She welcomes continued conversation and connection on LinkedIn.

Event venue & nearby stays

Tandoor Cuisine of India, 1132 E Katella Ave, Orange, United States

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