Dilip Palanisamy
Manager, Quality Systems @Tecomet, Inc
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WORK HISTORY
Manager, Quality Systems @Tecomet, Inc
Summary: Globally, providing overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations.Responsibilities:•Oversee and implement an advanced level of world-class quality systems for planning, DOE, ISO 13485, ISO 9001, AS9100, AS13100, ITAR/EAR, QFD, DFM, QIP, for 14 sites in US, Europe, and Asia•Integrating the quality function with manufacturing as a value added (real-time) support function, optimizing the continuous quality improvement process, while reducing cost and improving customer relationships.•Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity and maximize the profit margins for •Providing organizational assessments to upper management•Enhancing company systems interface capabilities while optimizing the capabilities to perpetuate harmonized systems improvements through deployment of best practices from the collective experience contribution of the worldwide teams.•Focus on continual quality improvement, while aligned with internal and external customer expectations. •Ensuring the organization is basing improvement related decisions on factually/meaningful data, subsequently reducing waste and expediting the recognition of favorable results.•Leadership responsibility for promoting and developing the Tecomet Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); NPD, NPI, and Worldwide Supplier Quality Systems.•Creating and managing high performing work teams
EDUCATION
University of Memphis
Bachelor of Science (B.S.), Biology, Chemistry; Engineering Technology
University of Memphis
Bachelor of Science (B.S.)
University of Memphis
Master of Business Administration - MBA
The University of Memphis
Master of Public Health (MPH), Epidemiology
SKILLS
ABOUT DILIP PALANISAMY
Results-driven manufacturing and quality professional with over 12 years of experience in the medical device industry, specializing in manufacturing engineering, supplier quality, and quality management systems. Proven track record of driving operational excellence, improving product reliability, and ensuring regulatory compliance within ISO 13485 and FDA environments.Skilled in process validation, CAPA systems, risk management, and supplier development, with a deep understanding of Lean and Six Sigma methodologies. Known for bridging the gap between engineering and quality by developing data-driven solutions that reduce defects, improve yields, and enhance product lifecycle performance.Collaborative leader with experience working cross-functionally with R&D, manufacturing/production, operations, and supply chain teams to launch new/legacy products and sustain high-performance manufacturing operations. Adept at guiding teams through audits, implementing robust process controls, and building continuous improvement cultures aligned with ISO 9001, 13485, and AS9100 standards.Passionate about advancing healthcare technologies through precision manufacturing and disciplined quality execution. Committed to delivering superior outcomes for patients, customers, and regulatory bodies by designing processes that meet stringent quality and safety standards.
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