2026 - February ASQ Orange Empire, Section 0701, Monthly Meeting

______________________________________________________________________________

Supplier process validation is a foundational element of product quality, patient safety, and regulatory compliance within the global medical device supply chain. As organizations expand and diversify their supplier networks, inconsistencies in validation rigor—driven by varying risk levels, regional practices, and process complexities—create challenges in maintaining standardization, audit readiness, and lifecycle control. This paper introduces a streamlined, risk‑tiered supplier process validation framework aligned with global regulatory expectations, including FDA 21 CFR 820, EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP, and country‑specific GMP requirements.

The proposed model integrates proven methodologies from automotive standards such as IATF 16949, AIAG PPAP, and APQP to establish scalable validation pathways tailored to supplier criticality and patient‑impact risk. By defining differentiated requirements for high‑, medium‑, and low‑risk suppliers—supported by harmonized documentation packages, capability‑based acceptance criteria, and structured revalidation triggers—the framework enhances transparency, reduces qualification cycle times, and strengthens global compliance. Benchmarking against automotive rigor further highlights opportunities to elevate process robustness, advance supplier maturity, and drive consistent execution across regions. The resulting unified, globally applicable model enables proactive supplier development, mitigates supply chain risk, and reinforces end‑to‑end quality assurance across the medical device ecosystem.

Manish Bathija is a biomedical engineer and global quality leader with more than two decades of experience advancing supplier quality, regulatory compliance, and external manufacturing excellence across the medical device industry. Based in Oak Park, California, he has led large, diverse teams across 15 global manufacturing sites, driving strategy, operational rigor, and cross‑functional alignment for Class II and III devices. His expertise spans supplier development, risk mitigation, process validation, and audit readiness, supported by deep knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and EU MDR/IVDR requirements.

Throughout his career at Medtronic, Advanced Bionics, and the Alfred Mann Foundation, Manish has built high‑performing organizations, standardized enterprise‑wide quality systems, and delivered measurable improvements in cost, quality, and capacity. A certified lead auditor and champion of inclusive leadership, he has also shaped talent development through initiatives such as the Global Supplier Quality University and his long‑standing engagement as a USC Brand Ambassador. He is recognized for his ability to elevate supplier partnerships, strengthen global operations, and enable innovation through disciplined, people‑first leadership.

_____________________________________________________________________________

The 2025 Cy Young Awards offer a perfect reminder of a mistake I see in root-cause analyses all the time: confusing an interesting coincidence with an actual cause. Two things can be true at once; it doesn't necessarily mean one "caused" the other. Let's dive deeper into the 2025 Cy Young awards as an example and learn more about the difference.

Ken is a proud graduate of the University of Arizona with a BS in Chemical Engineering. He has held many positions in the manufacturing space, while continuously advancing his career. He started at Procter and Gamble (P&G) after graduation, where he learned many of the principles he would successfully apply later. After leaving P&G, Ken went on to a career as a senior executive at several family/privately owned companies in the industrial, packaging and aerospace industries. Early during this time, Ken became a Lean/Sigma Champion, and used that passion to drive his companies' successful results. Ken recently retired as a COO and has started to work with Akhilesh Gulati as a member of the PIVOT Management Consulting team.

Event Venue & Nearby Stays

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

Concerts, fests, parties, meetups - all the happenings, one place.

Get App