A passion for Quality and a desire to make a difference, drives my 11 years of successful, diverse and fast-growing career in Quality Assurance and Management in the Medical Devices industry. I have rich work experience across electromechanical, mechanical and software products, with core medical device organisations ranging from a start-up, to medium sized, to large sized MNC.My quest for learning and the zeal to go above and beyond, enabled me to take up various roles in Manufacturing Quality Assurance, Quality Management System, Mechanical Design Assurance Lab Supervision, Supplier Quality and Software Quality Assurance. While my Masters (M.Tech) in Biomedical Engineering keeps me curious about the medical device industry, my MBA in Quality Management equips me to enhance my strategic leadership in the roles across products and organisations.My strong communication skills (written/verbal/interpersonal), analytical aptitude and adaptable attitude has effortlessly empowered me to enhance my leadership abilities while driving key and high impact projects for diverse stakeholders across the geographies of India, United States, Europe and APAC.Profile Highlights QMS: SME in Implementation, Maintenance & Certification of end to end Quality Management System for Design & Development of Medical Devices at 5 different sites in India, APAC & USA, per ISO 13485:2016, MDSAP including 21 CFR 820 and IEC 62304:2015. Acquainted with ISO 9001:2015 requirements also. Internal and Notified Body Audits: Certified ISO 13485:2016 Internal and Lead Auditor. Led and Facilitated 10+ internal and external (Supplier & Notified Body) audits as the front room SME & Auditee, Backroom Manager and Lead Auditor for internal audits while mentoring other budding auditors in the areas of Supplier Controls, Purchasing, Quality Systems, Training & Human Resources, Document Control and Design Controls including Risk Management.Software Quality Assurance: Leading the adoption of Software Development Life Cycle (SDLC) for product quality compliance to IEC 62304:2015, ISO 14971:2019 and 21 CFR part 11 for multiple product releases across 10 SaMD products. CAPA: Led and mentored 25+ CAPAs to implementation with 100% effectivity rate. Visit the Experience Section for More. Beyond Work, I am a Neuroscience enthusiast, a certified Neuro-Linguistic Programming (NLP) Practitioner and currently mastering Emotional Intelligence Coaching and other NLP based Coaching models. Music and Books keep my vibe in check, and I am currently enjoying reading The Power of Now by Eckhart Tolle.
Listed skills include Biomedical Engineering, Manufacturing, Medical Devices, Medical Imaging, and 33 others.
