Siddhartha Achyuta

Engineering Leadership | Expert in Medical Device Supplier, Manufacturing and Source Quality | Driving FDA & ISO 13485 Compliance | Delivering Operational Excellence & Strategic Supplier Partnerships

Role
Manager, Supplier Quality Engineering at Endologix LLC
Location
Atlanta, GA, US
LinkedIn followers
500 followers
Supply Chain & LogisticsView LinkedIn profile

About Siddhartha Achyuta

Knowledge of supplier and source quality methodologies• Designed and developed Engineering Systems• Detailed knowledge of ISO 13485, ISO 14971, ISO 9001, 21 CFR 820 and AS9100 • Certified Lean Six Sigma Green Belt• Solid leadership and teamwork skills

Experience

  1. Manager, Supplier Quality Engineering

    Endologix LLC

    May 2024 — Present · Cumming, GA, US

    Manage Supplier Quality Department. Mentor engineers within the supplier quality group and provide technical expertise for successful completion of assigned tasks and projects. Overhauled supplier audit process, achieving 100% completion of planned audits and maintaining zero major findings during regulatory inspections.2. Implemented supplier scorecard metrics that improved on-time delivery by 30% and reduced supplier defect rate by 40% in the first year.3. Partner with R&D and Operations to integrate suppliers into NPI phases, reducing supplier qualification cycle time by 20%Responsibilities:• Lead and mentor a team of Supplier Quality Engineers, setting strategic objectives, monitoring KPIs, and ensuring alignment with corporate quality goals.• Manage the global Supplier Quality Management Program, ensuring compliance with FDA, ISO, and EU MDR requirements.• Hire, manage, coach, and develop a small team of engineers with supplier quality expertise.• Set team goals, metrics tracking, and ensure results are achieved towards company objectives.• Lead supplier quality forums and provide appropriate metrics to drive cross functional activities.• Perform thorough audits and assessments of Supplier processes and QMS and drive improvement. Day-to-day activities include; supplier auditing, SCAR management, Supplier NCMR investigations, Supplier file maintenance, Supplier metrics, ASL and ACL management.• Core team member on supplier related projects starting in new product development.• Assess the Supplier Management process and related procedures for continual improvement. Support in-house manufacturing and customer complaint issues related to supplier parts.• Lead/Support for Quality Agreement and Change Agreements, supplier assessments and supplier audit process

Education

  • University of North Texas

    Master's degree, Engineering Technology - Mechanical Systems

    2014 — 2015

  • Jawaharlal Nehru Technological University

    Bachelor of Engineering - BE, Mechanical Engineering

    2009 — 2013

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Siddhartha Achyuta — Manager, Supplier Quality Engineering at Endologix LLC in Atlanta, GA, US | Unifers