Senior Quality Systems Lead — eQMS & Compliance

Lexington Medical, Inc.; Bedford; On-site; GBP 83,000 - 91,000; Full time

Job summary

Lexington Medical designs and manufactures AEON™ surgical stapling technology at our Bedford, MA headquarters. We seek a Senior Quality Systems Specialist to own the eQMS (Arena) and keep it compliant with ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, and EU MDR, driving CAPA, change control, supplier quality, and quality metrics.

You will partner with Operations, Engineering, Regulatory, and Manufacturing to maintain audit readiness for certifications and regulatory inspections in a fast-paced

Qualifications

• Bachelor's degree in a technical, scientific, engineering, or related discipline.
• 3–5+ years of medical device quality experience, hands-on with eQMS.
• Strong knowledge of ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, EU MDR.

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.

Skills

eQMS Admin

Quality metrics

Audits & inspections

Regulatory knowledge

Risk-based thinking

Education

Bachelor's degree in technical/science

Tools

Arena eQMS

MS Office

Job description

Lexington Medical designs and manufactures AEON™ surgical stapling technology at our Bedford, MA headquarters. We seek a Senior Quality Systems Specialist to own the eQMS (Arena) and keep it compliant with ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, and EU MDR, driving CAPA, change control, supplier quality, and quality metrics.

You will partner with Operations, Engineering, Regulatory, and Manufacturing to maintain audit readiness for certifications and regulatory inspections in a fast-paced