Headline

Biomedical Engineer- RA/QA Medical Device QMS & Compliance Operations | ISO 13485 | CAPA | Audit Support | Document Control | SOPs | Immediate Joiner

About

I am a medical device QMS and compliance operations professional with 6+ years of experience in medical device consulting, Quality Management Systems (QMS), ISO 13485 compliance, SOP implementation, CAPA management, document control, audit support, and cross-functional project coordination. As an Assistant Manager – Operations at Elexes Medical Consulting, I contribute to QMS implementation and maintenance, oversee quality records and document control activities, manage DCNs and change order logs, track CAPA actions, ensure documentation accuracy and completeness, and collaborate with RA/QA, technical, project, and operations teams to support compliance and operational excellence. My experience includes SOP development and review, QMS documentation management, audit preparation and coordination, KPI monitoring, statistical reporting, process improvement initiatives, and ensuring adherence to quality and regulatory requirements across multiple medical device projects. I have also supported SDLC compliance activities aligned with ISO 13485 and IEC 62304 standards. I am passionate about driving quality, compliance, and process efficiency within regulated environments and am interested in opportunities related to Quality Assurance, QMS, Compliance Operations, Document Control, CAPA Management, Audit Support, Medical Device Documentation, and Project Coordination.

Location

Greater Bengaluru Area

Work experience

Assistant General Manager Operations at Elexes Medical Consulting LLC, Aug 2025 - Present · 11 mos, India

Senior Compliance Specialist at Elexes Medical Consulting LLC, Jan 2022 - Sep 2025 · 3 yrs 9 mos, Bengaluru, Karnataka, India

Biomedical Engineer at Elexes Medical Consulting LLC, Jan 2021 - Jan 2022 · 1 yr 1 mo, India

Coordinator at Adroitt Medis s Solutions, Jan 2020 - Dec 2020 · 1 yr, Bengaluru, Karnataka, India

Advance Training at Harvey Biomedical, Nov 2019 - Jan 2020 · 3 mos, Bangalore, Have done advance training in 25 various biomedical equipments.

Education

Medical equipments, Harvey Biomedical

Higher secondary, Biology/Biological Sciences, General, Army Public School (APS)