Senior Quality Systems Specialist

Job overview

The Senior Quality Systems Specialist role is onsite at Lexington Medical’s headquarters in Bedford, MA, with an annual salary range of $110,000–$120,000. Lexington Medical designs and manufactures surgical stapling technology used in minimally invasive surgery. The specialist owns and improves the electronic Quality Management System and its core processes, helping maintain regulatory compliance and audit readiness. By partnering with Operations, Engineering, Regulatory, and Manufacturing, the role supports reliable product quality as processes and products change.

What you'll do

• Administer, maintain, and improve the eQMS across its lifecycle
• manage document and change control, training, CAPA, nonconformance, audits, risk management, and production controls
• conduct supplier qualification, monitoring, change review, and audits
• analyze QMS metrics and prepare management review inputs
• own CAPA investigations, root-cause analysis, and effectiveness verification
• plan and execute eQMS validation and 21 CFR Part 11 assessments
• maintain SOPs and QMS documentation
• support internal, supplier, certification, and regulatory audits and inspections.

What we're looking for

Skills & competencies

senior quality systems specialist

lexington medical

bedford ma

onsite

full-time

$110k–$120k annually

medical devices

eqms

arena

capa

iso 13485

regulatory audits

Work arrangement

• Weekend coverage required

Why this role

Hands-on ownership of Arena eQMS; supports ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, and EU MDR compliance; AI tool use is expected for drafting, analysis, and trending, with verification of outputs.

About the employer

Lexington Medical, Inc. is hiring for this role. Industry: Surgical Appliance and Supplies Manufacturing. Sector: 33.