---
title: 'Senior Quality Systems Specialist at Lexington Medical, Inc.'
canonical: 'https://feeny.ai/job/senior-quality-systems-specialist-lexington-medical-inc-bedford-sbkrhfn24q87'
type: 'job'
last_seen: '2026-10-16'
---

# Senior Quality Systems Specialist at Lexington Medical, Inc.

- **Company:** Lexington Medical, Inc.
- **Location:** Bedford, MA
- **Compensation:** $110k–$120k
- **Posted:** 2026-10-02
- **Last confirmed live:** 2026-10-16
- **Apply:** https://job-boards.greenhouse.io/lexingtonmedical/jobs/5442341008

## Job description

## About Lexington Medical

Lexington Medical designs and manufactures AEON™ surgical stapling technology at our headquarters in Bedford, Massachusetts, just outside Boston. Our products are used in minimally invasive surgery, where precision, reliability, and quality matter every time. Because engineering, manufacturing, regulatory and quality work together under one roof, the people building and supporting our products are close to both the process and the decisions behind it.

## About the Role

As a Senior Quality Systems Specialist at Lexington Medical, you will be the hands-on owner of our Quality Management System, working directly in the eQMS (Arena) every day while partnering with Operations, Engineering, Regulatory, and Manufacturing. You will keep the system compliant with ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, and EU MDR, and you will look for practical ways to make core processes like document control, CAPA, nonconformance, and supplier management work better for the people who use them.

This is an individual contributor role with real ownership. You will own the administration of eQMS (Arena), trend quality data for management review, run supplier quality activities, drive CAPA management and help keep the company audit-ready for certification and regulatory audits.

## Responsibilities

- Administer, maintain, and improve our electronic Quality Management System (eQMS) across its full lifecycle, keeping it effective and compliant with ISO 13485, 21 CFR Part 11, FDA QMSR, MDSAP, and EU MDR.
- Run and continuously improve core QMS processes and workflows, including document and change control, training, CAPA, nonconformance, internal audits, risk management, and production and process controls.
- Execute supplier quality activities, including supplier qualification and monitoring, supplier change review, supplier audits, and maintenance of supplier quality records.
- Collect, analyze, and trend QMS metrics and quality KPIs, flag emerging issues early, and prepare management review inputs that show leadership how the quality system is performing.
- Own the CAPA system, ensuring investigations, root-cause analysis, and effectiveness verification are completed on time.
- Plan and execute eQMS computer system validation and 21 CFR Part 11 assessments for configuration changes, upgrades, and new modules.
- Maintain and improve SOPs and related QMS documentation so they stay aligned with U.S. and international medical device requirements.
- Partner with Operations, Engineering, Regulatory, and Manufacturing to keep product quality and QMS compliance on track as processes and products change.
- Keep the organization audit-ready and participate actively in internal, supplier, certification, and regulatory audits, including MDSAP, EU MDR, and FDA inspections.

## Qualifications

- Bachelor's degree in a technical, scientific, engineering, or related discipline.
- 3+ years of medical device quality experience, including hands-on experience implementing, administering, and maintaining an electronic Quality Management System (eQMS).
- Hands-on experience with core QMS processes, including document and change control, CAPA, training, nonconformance, audits, and quality metrics.
- Strong working knowledge of medical device quality regulations and standards, such as ISO 13485, ISO 14001, FDA QMSR, 21 CFR Part 11, MDSAP, and/or applicable EU MDR requirements.
- Experience preparing for and supporting external audits and inspections, such as ISO 13485, MDSAP, EU MDR, and FDA.
- Proven ability to build, analyze, and manage QMS reporting metrics that support data-driven decisions across the organization.
- A systematic, practical problem solver who applies risk-based thinking to quality processes and decisions, and who can influence peers across functions to drive quality improvements.
- You use AI tools regularly to move faster on drafting, analysis, and trending, and you know when to trust the output and when to verify it.
- Experience with Arena eQMS is strongly preferred. ISO 13485 Lead Auditor, ASQ CQA, or ASQ CQE certification is a plus.

Location & Work Arrangement

This position is based at our headquarters in Bedford, Massachusetts, in the Greater Boston area, and is an on-site role.

Visit our [Candidate Journey page](https://lexington-med.com/candidate-journey/) to learn what to expect from our hiring process. Salary Range $110,000—$120,000 USD

## About Lexington Medical, Inc.

## Company Overview
- **One-liner**: Lexington Medical, Inc. designs and manufactures surgical stapling solutions, including the AEON Endostapler and AEON Powered platform, used in thoracic, bariatric, colorectal, and general surgery.
- **Entity Type**: Private (funding stage: Growth/Private Equity; latest round $37.8M led by Ampersand Capital Partners in 2025)
- **Headquarters**: Bedford, Massachusetts, United States
- **Founded**: 2013
- **Founders**: Leon Amariglio (CEO) and Tak Cheung (Co-Founder)

## Core Business
- **Primary industry**: Medical Equipment Manufacturing – Surgical Stapling
- **Target customers**: Hospitals, surgeons, and healthcare providers (B2B); customers in nearly 40 countries
- **Mission/purpose**: To build the world’s best surgical stapler and set a new standard for patient outcomes in the operating room.

## Products & Services
- **[AEON Endostapler](https://lexington-med.com/)**: Manual surgical stapler offering industry‑best clinical performance across multiple surgical specialties.
- **[AEON Powered Stapling System](https://lexington-med.com/)**: Powered precision and intelligent firing platform that expands on the manual stapler’s performance, designed to improve consistency and outcomes.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private company)
- **Key Metric**: Annual Revenue ~$22.5M (2025 estimate) | Total Funding $37.8M (last round: Private Equity, May 2025, led by Ampersand Capital Partners)
- **Notable Investors/Partners**: Ampersand Capital Partners (lead investor in latest round); other prior investors include unnamed backers in Series A (2016) and Series B (2018)
- **Growth Signals**: Headcount grew 21.8% YoY (96 employees); operates in 12 countries and supports surgeons in nearly 40 countries; active job postings increased 66.7% year‑over‑year; recent global expansion into Europe, Asia Pacific, and the Middle East.

## Competitive Advantages
- **Single‑category focus** – concentrates engineering and R&D entirely on surgical stapling, enabling rapid iteration and deep expertise.
- **US‑based manufacturing** – operates a 30,000‑sq‑ft engineering and manufacturing facility in Bedford, MA, allowing tight quality control and fast design‑to‑production cycles.
- **Nimble, customer‑driven innovation** – small teams with direct surgeon feedback loops; product improvements are implemented quickly.
- **Clinical performance** – the AEON platform is positioned as “industry‑best” in staple formation and reliability, backed by surgeon adoption among key opinion leaders.

## Strategic Focus
- **Global expansion** – scaling commercial presence in Europe, Asia Pacific, and the Middle East (recent hires in Switzerland, Australia, Germany, Israel, and more).
- **Product development** – continuous improvement of the AEON platform (both manual and powered) and expansion of the powered stapling system.
- **Talent acquisition** – actively hiring across engineering, manufacturing, sales, and supply chain to support international growth and product innovation.

## Why Work Here
- **Culture**: Small, fast‑moving teams where employees take on real responsibility early and see their work directly impact live surgical procedures. Core values: Delivery & Speed, Collaboration, Ownership, Focus & Excellence, Curiosity.
- **Work environment**: Headquarters in Bedford, MA; field‑based commercial roles globally. Flexible time off, medical/dental/vision insurance, 401(k) with company match, paid parental leave, and life insurance.
- **Engineering culture**: Engineers work on a single, high‑stakes product category; “very little distance between the work and how it performs in practice.” Emphasis on continuous learning, accountability, and cross‑functional collaboration.
- **Growth trajectory**: High growth (headcount up 21.8% YoY, revenue $22.5M) with a clear mission and expanding global footprint – ideal for professionals who want to build and scale a disruptive medtech company.

## Sources
1. [lexington-med.com](https://lexington-med.com/) – Company overview, products, culture, founder message
2. [lexington-med.com/careers](https://lexington-med.com/careers/) – Career page with values, benefits, employee testimonials
3. [linkedin.com/company/lexington-medical-inc-](https://www.linkedin.com/company/lexington-medical-inc-) – Company details, financials, headcount, funding, executive team
4. [job-boards.greenhouse.io/lexingtonmedical](https://job-boards.greenhouse.io/lexingtonmedical) – Current job openings across engineering, sales, supply chain

## Other roles at Lexington Medical, Inc.

- [Quality Control Technician](https://feeny.ai/job/quality-control-technician-lexington-medical-inc-bedford-pry2cgn2m4j9) — Bedford, MA
- [Territory Manager - Surgical Stapling](https://feeny.ai/job/territory-manager-surgical-stapling-lexington-medical-inc-london-0960gp0k468q) — London, United Kingdom
- [Global Strategic Marketing Manager](https://feeny.ai/job/global-strategic-marketing-manager-lexington-medical-inc-bedford-fzrjcmqk6fn1) — Bedford, MA
- [Mechanical Engineering Manager](https://feeny.ai/job/mechanical-engineering-manager-lexington-medical-inc-bedford-q0rbrkb2zazt) — Bedford, MA
- [Manufacturing Automation Engineer](https://feeny.ai/job/manufacturing-automation-engineer-lexington-medical-inc-bedford-n2wywhwwsxj1) — Bedford, MA
- [Sales Associate - Medical Device](https://feeny.ai/job/sales-associate-medical-device-lexington-medical-inc-austin-s60ncf81q24k) — Austin, TX
- [Mechanical Engineering Co-Op](https://feeny.ai/job/mechanical-engineering-co-op-lexington-medical-inc-bedford-zr7mezk2g5ae) — Bedford, MA
- [Electrical Engineer](https://feeny.ai/job/electrical-engineer-lexington-medical-inc-bedford-f8k2ftv1ks0y) — Bedford, MA
- [Embedded Software Engineer](https://feeny.ai/job/embedded-software-engineer-lexington-medical-inc-bedford-xeeq6r0xm0qr) — Bedford, MA
- [Manufacturing Engineering Intern](https://feeny.ai/job/manufacturing-engineering-intern-lexington-medical-inc-bedford-th8nqdacsnf5) — Bedford, MA