Shantha Samarasinghe
Quality Engineering Manager at Abbott | Maple Grove, Minnesota, United States
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Shantha Samarasinghe is a distinguished Quality Engineering Manager at Abbott, where he plays a pivotal role in ensuring the highest standards of quality and compliance across worldwide manufacturing locations. With a robust background in the medical device industry, Shantha expertly navigates the complexities of the evolving quality and regulatory landscape, leveraging his extensive expertise in quality systems and supplier management. His leadership is characterized by a commitment to excellence, as evidenced by his successful track record in recruiting, hiring, and supervising high-performing teams dedicated to quality assurance and continuous improvement.
In his current role, Shantha manages a dynamic engineering group responsible for critical functions such as supplier selection, evaluation, and qualification. He has implemented a risk-based supplier categorization system that optimizes resource utilization and aligns with Abbott's strategic business objectives. This innovative approach not only enhances supplier performance assessment but also streamlines the supplier corrective action (SCAR) and change notification processes (SCN/SCR), ensuring that all components meet stringent regulatory requirements.
Shantha’s expertise extends to leading new product introductions, where he oversees the qualification of new components, ensuring they adhere to rigorous standards such as ISO 10993 and Good Manufacturing Practices (GMP). His proficiency in process validation (IQ, OQ, PQ) and quality audits further solidifies his role as a key player in maintaining Abbott's reputation for quality and safety in medical devices. Through his critical thinking and problem-solving skills, Shantha continues to drive improvements that not only meet but exceed industry standards, making him an invaluable asset to Abbott and the broader medical device community.
Quality Engineering Manager at Abbott in January 2018 to Present
Corporate Supplier Quality Engineering Lead at Ecolab in January 2013 to January 2018
Lead Quality Engineer at Greatbatch Medical in January 2011 to January 2013
Senior Principal Engineer (Quality Engineering & Regulatory Leader) at Medtronic in January 2002 to January 2011
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University of Illinois Urbana-Champaign
University of Colombo
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Certified Lead Auditor
Project Management
Continuous Improvement
Audits
ISO 13485, ISO 9001
PPAP
Risk Management
Medical Device 21 CFR 820
Pharmaceuticals 21 CFR 210 and 211
Quality System
Process Validation (IQ, OQ, PQ)
LCMS, GCMS, ICP-MS
ISO 10993
Design Verification
Analytical Techniques
LIMS
TMV
NCMR
Quality Audits
SCAR
SCN/SCR
Performance Metrics
Change Notifications
Control Plan, PFMEA, (cpk/ppk)
Corrective and Preventive Action (CAPA)
Supplier Evaluation & Selection
Supplier Audits
Supplier Development
Supplier Risk Assessment
Process Qualification & Validation
Validation
GMP
CAPA
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Discover more about AbbottWhat is Shantha Samarasinghe email address?
Email Shantha Samarasinghe at [email protected]. This email is the most updated Shantha Samarasinghe's email found in 2026.
How to contact Shantha Samarasinghe?
To contact Shantha Samarasinghe send an email to [email protected]. (updated on September 17, 2024)
What company does Shantha Samarasinghe work for?
Shantha Samarasinghe works for Abbott
What is Shantha Samarasinghe's role at Abbott?
Shantha Samarasinghe is Quality Engineering Manager
What is Shantha Samarasinghe's Phone Number?
Shantha Samarasinghe's phone (218) ***-*385
What industry does Shantha Samarasinghe work in?
Shantha Samarasinghe works in the Medical Devices industry.
Shantha Samarasinghe Email Addresses
Shantha Samarasinghe Phone Numbers
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