“Kirit is a highly skilled and driven engineer. He will accomplish the job regardless of the challenge, he is experienced, and his qualifications give him a unique insight into the quality engineering and QMS process. truel leader/ added value.”
Kirit Patel
Burlington, Massachusetts, United States
562 followers
500+ connections
562 followers
500+ connections
About
Accomplished Quality Engineer with over 20 years’ experience in dealing with life…
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Past Education Co-Chair
ASQ Merrimack Valley - Section 0102
- 1 year 1 month
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Chris Whelan
If you needed any more convincing that FMEA is not risk management, look no further than FDA's Compliance Inspection Manual published 30-Jan-26. Risk is not just about failure modes. Risk is about anything that can go wrong, even when everything is working as intended. Risk assessment, evaluation and control must include use and user-related risks, design, process, supply chain, biological, clinical, environmental and more AND throughout the entire product life-cycle, not just pre-market. Manufacturers who've had a US-only focus must have this in their risk management system already because the transition period is over and FDA is not waiting for you! https://lnkd.in/gQr5gRgX
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Jonathan Ash
Risk-Based Thinking in Design Risk-based thinking is one of the most valuable habits in product and process development. Anticipating where failures or variation may occur allows you to address them before they reach the customer—or your bottom line. FMEA and design reviews aren’t checkboxes; they’re opportunities to learn, adjust, and strengthen your design’s resilience. Preventing problems will always cost less than fixing them. 🧭 Plan for Quality, Plan for Success 🥇 #Quality #APQP #DFMEA #PFMEA #ProductDevelopment #Engineering #Lean #DesignControl #Wispworks
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