Quality Systems Lead (Medical Devices/IVD)

Meridian Bioscience International Limited; North Billerica (MA); On-site; USD 70,000 - 112,000; Full time

Job summary

Meridian Bioscience is seeking a Quality System Specialist to oversee the Quality Management System in a regulated medical device/IVD environment. The role ensures compliance with 21 CFR Part 820 and ISO 13485, maintains documentation and processes, and uses metrics and risk-based thinking to drive improvements.

You will collaborate with Manufacturing, R&D, Regulatory Affairs, Product Support, and Supply Chain to strengthen compliance, readiness for inspections, and customer-focused quality,

Qualifications

• Bachelor's degree or equivalent in a related field.
• 3+ years in Quality Assurance or Quality Systems in regulated environments.
• Experience with eQMS and document control, CAPA, audits, and quality metrics.

Responsibilities

• Maintain and improve the Quality Management System (QMS) to ensure compliance with applicable requirements.
• Support audits, CAPA, nonconformance, and deviations; contribute to trend analysis.
• Prepare documentation for inspections and management reviews; monitor KPIs.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain.
• Ensure Good Documentation Practices and effective use of electronic QA systems.

Skills

Quality Assurance

Quality Systems

eQMS

21 CFR 820

ISO 13485

CAPA

Good Documentation

Data analysis

Cross-functional collaboration

MS Office

Risk management

Education

Bachelor’s degree in Quality, Engineering, Life Sciences, Business

Tools

ERP systems

Document management systems

Job description

Meridian Bioscience is seeking a Quality System Specialist to oversee the Quality Management System in a regulated medical device/IVD environment. The role ensures compliance with 21 CFR Part 820 and ISO 13485, maintains documentation and processes, and uses metrics and risk-based thinking to drive improvements.

You will collaborate with Manufacturing, R&D, Regulatory Affairs, Product Support, and Supply Chain to strengthen compliance, readiness for inspections, and customer-focused quality,