Quality Systems Specialist

Meridian Bioscience, Inc.•Billerica, MA

7d•$69,800 - $111,800

About The Position

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

Requirements

Bachelor’s degree in Quality, Engineering, Life Sciences, Business, or a related field, or an equivalent combination of education and relevant experience.
At least 3 years of Quality Assurance or Quality Systems experience in a regulated medical device, IVD, pharmaceutical, or life sciences environment.
Working knowledge of QMS 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.
Proficiency with Microsoft Word, Excel, and PowerPoint, and 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 and 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 appropriately escalating significant compliance or product-quality risks.
Demonstrated commitment to continuous improvement, customer requirements, data integrity, and inspection readiness.

Nice To Haves

Experience with electronic Quality Management Systems (eQMS).
Experience using electronic Quality Management Systems, document management systems, and/or ERP systems.

Responsibilities

Support maintenance and effective implementation of QMS 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, including documentation, root cause analysis, effectiveness checks, and closure activities.
Identify quality system improvement opportunities using metrics, trend analysis, risk-based thinking, and internal customer feedback.
Develop, maintain, analyze, and communicate Quality System KPIs and periodic metrics for management review and operational decision-making.
Facilitate cross-functional meetings and follow-up activities to ensure clear ownership, timely completion, and sustained compliance.
Support process improvements and quality system changes, including impact assessment, stakeholder communication, training coordination, and effectiveness monitoring.
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 internal stakeholders with guidance on Quality System procedures, Good Documentation Practices, and electronic quality systems.
Communicate quality issues, trends, risks, and recommended actions clearly and promptly to stakeholders and management.
Author, revise, review, and route quality system documents, including 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 the electronic QMS and related business systems, as applicable.
Perform other duties consistent with the scope and level of the position.