Quality Systems Specialist

The Quality System Specialist supports the effective operation, maintenance, and continuous improvement of Meridian Bioscience’s Quality Management System (QMS) within a regulated medical device/IVD environment. The role ensures quality system processes and documentation remain compliant with applicable regulatory requirements, standards, and company procedures, including 21 CFR Part 820 and ISO 13485. This position uses quality metrics, risk-based thinking, and data analysis to identify trends, support investigations, and drive sustainable improvements. The Specialist partners cross-functionally with Manufacturing, R&D, Regulatory Affairs, Product Support, Supply Chain, and other stakeholders to strengthen compliance, inspection of readiness, and customer-focused quality. The role is expected to work independently on assigned quality system activities and communicate quality information clearly to stakeholders and management.

Quality System Management & Compliance• Support the maintenance and effective implementation of Quality Management System processes, ensuring procedures and records remain current, controlled, and compliant with applicable requirements, including 21 CFR Part 820, ISO 13485, cGMP, and company procedures.• Execute and monitor document control and records management activities, including controlled documents, changes, periodic reviews, archival, and electronic QMS workflows

• Support inspection and audit readiness by preparing documentation, retrieving objective evidence, participating in internal, supplier, customer, and regulatory audits, and supporting timely responses to findings.• Support CAPA, nonconformance, deviation, complaint trending, and other quality system investigations as assigned, including documentation, root cause analysis, effectiveness checks, and closure activities.Continuous Improvement & Quality Metrics• Identify quality system improvement opportunities using metrics, trend analysis, risk-based thinking, and feedback from internal customers.• Develop, maintain, analyze, and communicate Quality System KPIs and periodic metrics to support management review and operational decision making.• Facilitate cross-functional meetings and follow-up activities to ensure clear ownership, timely completion, and sustained compliance.• Support implementation of process improvements and quality system changes, including impact assessment, stakeholder communication, training coordination, and effectiveness monitoring.Cross-Functional Collaboration• Partner with Manufacturing, R&D, Regulatory Affairs, Product Support, Marketing, Supply Chain, and other functions to promote compliant quality practices and improve product and process quality.• Provide guidance to internal stakeholders on Quality System procedures, Good Documentation Practices, and use of electronic quality systems.• Communicate quality issues, trends, risks, and recommended actions clearly and promptly to appropriate stakeholders and management.Documentation & Systems• Author, revise, review, and route quality system documents such as SOPs, work instructions, forms, reports, and quality records.• Maintain accurate, complete, traceable, and inspection-ready quality records in accordance with Good Documentation Practices and record-retention requirements.• Support administration, user adoption, and continuous improvement of electronic Quality Management System and related business systems, as applicable.• Perform other duties as assigned that are consistent with the scope and level of the position.

• Bachelor’s degree in Quality, Engineering, Life Sciences, Business, or a related field, or equivalent combination of education and relevant experience.
• Minimum 3+ years of Quality Assurance or Quality Systems experience in a regulated medical device, IVD, pharmaceutical, or life sciences environment.
• Experience with electronic Quality Management Systems (eQMS) strongly preferred.
• Working knowledge of Quality Management System requirements and quality practices, including 21 CFR Part 820, ISO 13485, cGMP, and Good Documentation Practices.
• Practical experience with document control, change control, CAPA, nonconformance/deviation processes, audits, training records, and quality metrics.
• Experience using electronic Quality Management Systems, document management systems, and/or ERP systems preferred.
• Proficiency with Microsoft Word, Excel, and PowerPoint; ability to organize and analyze quality data and communicate meaningful trends.
• Ability to apply critical thinking, risk-based thinking, root cause analysis, and structured problem solving to quality system issues.
• Strong written and verbal communication skills with the ability to collaborate effectively across functions and organizational levels.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities in a regulated, fast-paced environment.
• Ability to work independently with minimal supervision while escalating significant compliance or product-quality risks appropriately.
• Demonstrated commitment to continuous improvement, customer requirements, data integrity, and inspection readiness.
• Travel: 5%

Compensation Range: $69,800 to $111,800