Senior Quality Systems Lead – eQMS & Compliance

Lexington Medical, Inc; Bedford (MA); On-site; USD 110,000 - 120,000; Full time

Job summary

Lexington Medical, Inc. is seeking a Senior Quality Systems Specialist based at our Bedford, MA headquarters.

You will own and administer the eQMS (Arena), maintain compliance with ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP and EU MDR, and drive CAPA, document control, and supplier management processes. You will partner with Operations, Engineering, Regulatory and Manufacturing to keep product quality and QMS alignment as processes evolve, and you will support audits and regulatory inspections

Qualifications

• Hands-on quality systems experience in medical devices.
• Familiarity with eQMS (Arena) or similar systems.
• Knowledge of ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP and EU MDR requirements.
• Experience supporting external audits and inspections.

Responsibilities

• Administer and optimize the eQMS across its lifecycle.
• Ensure compliance with ISO 13485, 21 CFR Part 11, FDA QMSR, MDSAP and EU MDR.

Skills

Quality mindset

Risk-based thinking

Collaborative

Regulatory knowledge

Education

Bachelor's degree in technical/scientific/engineering

Job description

Lexington Medical, Inc. is seeking a Senior Quality Systems Specialist based at our Bedford, MA headquarters.

You will own and administer the eQMS (Arena), maintain compliance with ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP and EU MDR, and drive CAPA, document control, and supplier management processes. You will partner with Operations, Engineering, Regulatory and Manufacturing to keep product quality and QMS alignment as processes evolve, and you will support audits and regulatory inspections