Quality Systems Specialist: Compliance & Improvement

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

Job summary

Meridian Bioscience Inc. is seeking a Quality System Specialist to support and improve the QMS within a regulated medical device/IVD environment.

The role ensures compliance with 21 CFR Part 820, ISO 13485, cGMP, and Good Documentation Practices while leveraging data analysis to drive improvements. The candidate will collaborate with Manufacturing, R&D, Regulatory Affairs, Product Support, and Supply Chain, among others, to maintain inspection readiness and strong quality performance.

Qualifications

• Bachelor’s degree or higher in a related field.
• Minimum 3+ years in Quality Assurance or Quality Systems in a regulated environment.
• Experience with electronic Quality Management Systems (eQMS) preferred.

Responsibilities

• Maintain and implement Quality Management System processes to stay compliant.
• Manage document control, changes, reviews, archival, and QMS workflows.
• Support audits by preparing documentation and responding to findings.

Skills

Quality Management

Regulatory Compliance

Data Analysis

Cross-functional Collaboration

Documentation Practices

Communication Skills

Education

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

Tools

eQMS

Document Management System

ERP systems

Job description

Meridian Bioscience Inc. is seeking a Quality System Specialist to support and improve the QMS within a regulated medical device/IVD environment.

The role ensures compliance with 21 CFR Part 820, ISO 13485, cGMP, and Good Documentation Practices while leveraging data analysis to drive improvements. The candidate will collaborate with Manufacturing, R&D, Regulatory Affairs, Product Support, and Supply Chain, among others, to maintain inspection readiness and strong quality performance.