Senior Quality Systems Specialist

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