Vivek Shimpi · Quality · Product Dev · Analytics
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Vivek Shimpi

Product development · Quality systems · Analytics

Vivek Shimpi

Seven years building Class III devices, three governing the systems that release them — and the software and analytics underneath both.

A decade in medical devices: product development on a Class III implantable at Abbott, then global eQMS ownership and CAPA programmes at Avanos. The throughline is building — Python and LabVIEW instrumentation in R&D, and now the data pipelines and models that make quality data answerable.

What sets him apart View experience Résumé
01 About

I have spent a decade inside regulated medical-device quality — the kind of work where a record has to survive an audit and a process has to hold under scrutiny. Today I am Manager of Quality Systems & Continuous Improvement at Avanos Medical, where I own and administer the global eQMS (ETQ Reliance) — 2,000+ users across four manufacturing sites — lead a team of seven, and hold enterprise approval authority for computerised system validation.

The results are concrete: a 58% year-over-year reduction in quality nonconformances, closure of a 1,500-record complaint backlog, an FDA 483-linked CAPA closed from investigation to inspection close-out inside twelve months, and data pipelines trending up to 200,000 quality records per process for management review.

What makes that possible is the toolkit underneath. I taught myself Python and built LabVIEW instrumentation by hand inside a Class III implantable programme at Abbott. That fluency now points directly at the problems I own — most recently an analytics pipeline that codes raw complaint data to IMDRF terminology at 95% top-1 accuracy across key product lines.

I understand these systems because I can build them — which lets me modernise regulated infrastructure that most quality professionals can only specify.
02 Expertise

Quality and regulatory, with a builder's depth.

Quality management systems

Designing, administering and defending QMS processes built to ISO 13485 and the FDA Quality System Regulation — including audit readiness and management review.

ISO 1348521 CFR 820 / QMSR

CAPA & complaint programmes

Owning CAPA end to end and harmonising it across sites and business units — including an FDA 483-linked CAPA carried from investigation to inspection close-out.

CAPA ownershipFDA 483 responseComplaints & GPMS

eQMS ownership

Owns and administers a global electronic QMS — 2,000+ users across four manufacturing sites — the system of record for quality workflows and compliance data.

ETQ RelianceChange control

Post-market surveillance

Complaint intake, investigation and trending across the installed base — the highest-volume, hardest-to-trend data in the quality system — feeding GPMS and regulatory submissions.

TrendingRisk-based triage

Quality data & analytics

Data pipelines over up to 200k quality records per process, SQL and PowerBI executive dashboards, and an IMDRF complaint-coding model at 95% top-1 accuracy.

SQLPowerBIIMDRF coding

Software & equipment assurance

Enterprise approval authority for CSV, owner of the company's Computer Software Assurance governance, and CAPA lead for analytical instrument qualification.

FDA CSAGAMP 5USP <1058>
03 Differentiators

A foundation that's real, battle-tested, and pointed at quality.

A throughline of self-directed technical growth that consistently serves quality and regulatory goals. The foundation is the rock; analytics is simply where it is pointed.

01
Abbott · CardioMEMS · 2016–2023

Self-taught foundations

Developed Python test- and equipment-automation software and a controller GUI for design-feasibility testing, then led an agile team building the LabVIEW drivers and interface used for real-time in-vivo device testing. Hands-on engineering inside a Class III implantable programme — the technical skill is real, and it was forged in one of the most highly regulated device contexts there is.

PythonLabVIEWClass III implantable
02
Avanos · 2023–present

Systems ownership at scale

Owns and administers a global eQMS (ETQ Reliance) — 2,000+ users across four manufacturing sites — and builds the data pipelines that trend up to 200,000 quality records per process for management review. Holds enterprise approval authority for computerised system validation, and updated the enterprise CSV process to align with FDA Computer Software Assurance.

ETQ RelianceFDA CSAGAMP 5Data pipelines
03
Shipped · in production use

Machine learning inside the quality system

Built and trained an analytics pipeline that categorises raw complaint data to IMDRF standard coding at 95% top-1 accuracy across key product lines and annexes — the coding step that normally consumes analyst hours and drifts between reviewers. It sits inside a validated quality system, which is the harder half of the problem: in a regulated QMS a model is subject to the same scrutiny as any other quality-system tool, not exempt from it.

IMDRF coding 95% top-1 FDA CSA Tracking · FDA AI/ML guidance

The caveat is the credential. Every model statement pairs with its governance constraint — validated, auditable, human-in-the-loop — because that is the proof a system has been defended to an auditor. Risk-based assurance under CSA, not box-checking, and not technology for its own sake.

04 Experience
  • Owns and administers the global eQMS (ETQ Reliance) — 2,000+ users across four manufacturing sites — and directs a global team of seven.
  • Drove a 58% year-over-year reduction in quality nonconformances, closed a 1,500-record complaint backlog, and closed 84% of legacy CAPAs in 2025.
  • Implemented a risk-based complaint-investigation flow that cut low-risk complaint cycle time by 80%.
  • Builds data pipelines over up to 200,000 quality records per process, and led quality KPI development end to end — metric definition, SQL, reporting automation and PowerBI executive dashboards.
  • Built and trained an analytics pipeline categorising raw complaint data to IMDRF coding at 95% top-1 accuracy for key product lines and annexes.
  • Owns Computer Software Assurance governance for the company, updating the enterprise CSV process to align with FDA CSA, and holds enterprise CSV approval authority.
  • Led a USP <1058> CAPA, guiding and approving documentation for equipment qualification and software assurance.
  • Runs a year-long lunch-and-learn series teaching Excel and AI tooling, eQMS practice and project-management principles.
  • Earlier as Technical Quality Leader, Pain Management (Jan 2023 – Sep 2024): managed an FDA 483-linked complaint-process CAPA from investigation through verification of effectiveness and inspection close-out within twelve months.
ETQ RelianceISO 1348521 CFR 820GAMP 5FDA CSAPost-market surveillance
  • As Senior Product Development Engineer (2020–2023), directed new product design and development through requirements, DMR outputs and design verification — and led an agile team building the LabVIEW drivers, software and interface used for real-time in-vivo device testing.
  • Developed Python test- and equipment-automation software and a controller GUI to streamline design-feasibility testing.
  • Drove DHF remediation (Design Input/Output, V&V) that contributed to closing an FDA warning letter, and led cross-functional teams through design changes from feasibility to FDA notification.
  • Qualified new suppliers through to signed supplier agreements and manufacturing readiness.
  • Began as a co-op on next-generation device development — RF engineering, photolithography and SolidWorks.
PythonLabVIEWISO 14971Design controlsClass III implantable

Advisory roles held concurrently with the full-time roles above, not in place of them — the CLIP advisory ran for seven years alongside Abbott and Avanos.

  • As lead technology advisor to CLIP Retirement (2018–2026), designed commercial-ready production application architecture, infrastructure and distribution for a FinTech platform, and built a validated financial simulator in C# and Avalonia for evaluating real-world product performance projections.
  • Managed IT infrastructure, software validation and deployment pipelines across AWS, Google Cloud and CI/CD, plus company hosting, Microsoft cloud, user accounts and software licensing.
  • Identified and coordinated strategic development and distribution partners, evaluating capability and product fit.
  • As lead technology advisor to Weekly Audition (2020–2023), took inherited work and its stack to a fully deployed platform with an active user community — marketing site, user dashboard and admin portal on NextJS and Google Cloud, a Strapi GraphQL API, and subscription billing through Stripe, AWS and SendGrid.
  • Across other advisory engagements, delivered full-stack web applications spanning user dashboards, admin portals, API integrations and database architecture, and trained non-technical founders in secure computer use and business technical setup.
C#TypeScriptNextJSAWSGoogle CloudCI/CDSoftware validation
05 Credentials
Georgia Tech B.S. in Biomedical Engineering, minor in Materials Science & Engineering — the foundation behind the quality work. Georgia Institute of Technology · 2016
PMP Project Management Professional — disciplined delivery of cross-site quality initiatives. Project Management Institute · 2021
ISO 13485 (TPECS) QMS competency certificate in the medical-device standard I administer day to day. BSI · 2024
Full-Stack Development Intensive programme in JavaScript, React, Node, databases and deployment — the formal half of the self-taught engineering. Georgia Tech Coding Bootcamp · 2019
Six Sigma Green Belt Statistical process capability and trend analysis behind the continuous-improvement portfolio. Process improvement
Languages English (native), Spanish (fluent), German (beginner), ASL (basic). Working proficiency
06 Personal

The same hands-on habit, off the clock.

A few things that keep the curiosity — and the craft — sharp.

Animal fostering An active dog and cat foster with Furkids and Cats4Life. Furkids · Cats4Life
Sewing An intermediate sewist who enjoys making garments for himself and his wife. Garment making
Building for its own sake Personal applications and published developer tooling — an AI vision tool for ALCOA+ documentation checks, and a TypeScript test toolkit on npm. Personal projects
07 Contact

Open to quality & regulatory leadership — and quality-data work.

Manager and director-level roles in medical-device quality systems, CAPA and post-market programmes, and the analytics that sit inside them. Atlanta metro or remote.

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