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Amit Paul

@amitpaul

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I am a Medical Device Quality Assurance lead with 10+ years driving QMS, compliance, and risk management.

India

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What I'm looking for

I seek senior QA roles in medical devices to lead QMS implementations, drive regulatory readiness, mentor teams, and apply data-driven risk management in collaborative, audit-ready environments.

I am a Medical Device Quality Assurance professional with over a decade of experience delivering audit-ready quality systems and product compliance. I specialize in end-to-end quality assurance across design, production and post-market activities for complex medical products.

I drive design control processes and author or review critical lifecycle documentation including Design History Files (DHF), Software V&V artifacts, and Device Master Records (DMR). I have led design transfer activities, established traceability between requirements and risk controls, and supported regulatory submissions for patient monitoring, imaging, SaMD and implantable products.

I lead QMS implementation, CAPA, audits and supplier qualification, and have participated in multiple ISO 13485, MDSAP and regulatory authority inspections. I have managed and coached teams, led investigations and maintained zero CAPA overdues while improving complaint analysis and trending using Power BI (30% efficiency gain).

I hold recognized certifications in EU MDR, ISO 14971 and ISO 13485 auditing and bring a practical, data-driven approach to compliance and continuous improvement. I seek roles where I can strengthen product safety, regulatory readiness and team capability in a collaborative, quality-focused environment.

Experience

Work history, roles, and key accomplishments

Senior Quality Assurance Lead

GE Healthcare

Feb 2023 - Jul 2025 (2 years 5 months)

Led design control and product quality activities for patient monitoring and imaging products, establishing DHFs/DMRs and RMFs; participated in 6 ISO/MDSAP/EU MDR audits, 3 regulatory audits and 14 inspections while managing CAPAs with 0 overdues.

Design Control Risk Management CAPA ISO 13485 Trackwise

Senior Quality Engineer

Stryker

Sep 2021 - Feb 2023 (1 year 5 months)

Led QMS harmonization across acquired entities and supported EU MDR transition by updating Technical Files and authoring PMS plans/PSURs for Class III implants; managed a team of 7 and improved regulatory readiness and inspection outcomes.

EU MDR CAPA Team Management Statistical Analysis Root Cause Analysis

Complaint Investigator

Philips Healthcare

May 2019 - Sep 2021 (2 years 4 months)

Investigated product complaints, implemented CAPAs and adverse event reporting to EU/FDA, and supported PMS for Class II/III devices; enhanced complaint analytics with Power BI improving efficiency by 30%.

CAPA Adverse Events ISO 13485 Power BI Root Cause Analysis

Lead Engineer

Siemens Healthineers

Mar 2016 - May 2019 (3 years 2 months)

Acted as quality lead for design control across new and sustaining medical device projects, authoring DHFs and risk reports for SaMD to ensure compliance with IEC 62304/ISO 14971 and executing V&V and usability validations.

Design Control SaMD Risk Management EN 62304 ISO 14971 Validation Change Control ISO 13485

CAD Engineer Trainee

CADD Center

Sep 2015 - Jan 2016 (4 months)

Engineered 3D models and technical drawings using Siemens NX 10 with GD&T per ASME Y14.5, supporting remediation of legacy engineering documentation for medical device components.

3D Modeling GD&T

Graduate Trainee

CIPET

Jan 2015 - Aug 2015 (7 months)

Applied CAD/CAM to design medical-grade plastic disposables under ISO 13485 design controls, supported kaizen/lean initiatives and assisted in internal ISO audits.

CAD CAM ISO 13485 Quality Assurance