Senior Quality Systems Specialist

The role

You will own the Quality Management System and work daily in the eQMS (Arena). You will partner with Operations, Engineering, Regulatory, and Manufacturing to maintain compliance with medical device standards.

What you will do

• Administer, maintain, and improve the electronic Quality Management System (eQMS).
• Run and improve core QMS processes including document control, CAPA, and internal audits.
• Execute supplier quality activities including qualification, monitoring, and audits.
• Collect, analyze, and trend QMS metrics and quality KPIs.
• Own the CAPA system including investigations and root-cause analysis.
• Plan and execute eQMS computer system validation and 21 CFR Part 11 assessments.
• Maintain and improve SOPs and QMS documentation.
• Partner with cross-functional teams to keep product quality and compliance on track.
• Participate in internal, supplier, certification, and regulatory audits.

Required qualifications

• Bachelor's degree in a technical, scientific, engineering, or related discipline.
• 3+ years of medical device quality experience.
• Hands-on experience implementing, administering, and maintaining an 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 EU MDR requirements.
• Experience preparing for and supporting external audits and inspections.
• Ability to build, analyze, and manage QMS reporting metrics.
• Systematic, practical problem solver who applies risk-based thinking.
• Regular use of AI tools for drafting, analysis, and trending.

Nice to have

• Experience with Arena eQMS
• ISO 13485 Lead Auditor certification
• ASQ CQA certification
• ASQ CQE certification

About the company

Lexington Medical designs and manufactures AEON surgical stapling technology at its headquarters in Bedford, Massachusetts. Engineering, manufacturing, regulatory and quality work together under one roof.