This month, we're excited to spotlight @Nanda Filkin, Quality Assurance Scientist and Quality Auditor at Arete Biosciences.
With more than 20 years of experience across biological laboratory environments including R&D, manufacturing, Quality Assurance, GMP/GDP, and medical device quality systems, Nanda brings an incredible depth of knowledge to the Community. Most recently, she became certified as a Lead Auditor for ISO 13485:2016 and an Internal Auditor for MDSAP, with a growing focus on medical device management systems and audit-readiness assessments.
Nanda joined the Exemplar Global Community to continue developing her auditing expertise, connect with other professionals in the medical device sector, and gain more experience working alongside audit teams as a subject matter expert.
One piece of advice she shared really stood out:
Everyone has a different perspective and way of conducting audits. The key is to keep an open mind and keep the thread and conversation going without going off track and causing delays. Open dialogue and good communication are key to understanding the organization you are auditing, and trust is crucial for a thorough and successful audit.
Outside of auditing, Nanda is also passionate about fighting food insecurity and reducing waste. She co-founded Athens Food Rescue (AFR), a nonprofit in Athens, Ohio focused on redirecting food away from landfills and into food kitchens, pantries, and free fridge programs throughout the county.
Thank you, Nanda, for being part of the Community and for the meaningful work you're doing both professionally and personally.
If you work in the medical device auditing space or have experience with ISO 13485 or MDSAP, feel free to connect with Nanda in the comments below!
------------------------------
Jamie Gravatte
Community Manager
Exemplar Global
------------------------------