Quality Systems & Compliance Specialist

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

Job summary

Meridian Bioscience is seeking a Quality System Specialist to support the operation, maintenance, and continuous improvement of the Quality Management System (QMS) in a regulated medical device/IVD environment in Billerica, MA.

The role ensures documentation and processes comply with 21 CFR Part 820, ISO 13485, cGMP, and company procedures, while enabling cross-functional collaboration with Manufacturing, R&D, Regulatory Affairs, Product Support, and Supply Chain.

Qualifications

• Bachelor’s degree in Quality, Engineering, Life Sciences, Business, or related field.
• Minimum 3+ years in Quality Assurance or Quality Systems in regulated life sciences.
• Experience with electronic Quality Management Systems (eQMS) preferred.
• Working knowledge of 21 CFR Part 820, ISO 13485, cGMP and GXP.
• Experience with document control, change control, CAPA, audits, and quality metrics.
• Proficiency with MS Office and data interpretation.

Responsibilities

• Maintain and improve Quality Management System processes and records.
• Support audits, CAPA, nonconformance, and deviation investigations.
• Develop and communicate quality metrics and KPIs.
• Collaborate with Manufacturing, R&D, Regulatory, and Product Support.

Skills

Quality systems

Risk-based thinking

Document control

CAPA

Data analysis

MS Office

Cross-functional teamwork

Education

Bachelor's degree

Tools

eQMS

ERP systems

Job description

Meridian Bioscience is seeking a Quality System Specialist to support the operation, maintenance, and continuous improvement of the Quality Management System (QMS) in a regulated medical device/IVD environment in Billerica, MA.

The role ensures documentation and processes comply with 21 CFR Part 820, ISO 13485, cGMP, and company procedures, while enabling cross-functional collaboration with Manufacturing, R&D, Regulatory Affairs, Product Support, and Supply Chain.