Meridian Bioscience Inc. · 10 hours ago
Senior Quality Analyst
North Billerica, MA, US
Full-time
Onsite
Senior Level
7+ years expMeridian Bioscience, Inc. is a fully integrated life science company that develops innovative diagnostic products. The Senior Quality Analyst is responsible for leading Quality Assurance activities across the product lifecycle, applying technical knowledge and statistical methods within a regulated medical device environment.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
Responsibilities
Participate in and support CAPA, nonconformance, deviation, and statistical evaluation of complaint trending and other quality investigations using data-driven root cause and statistical analysis techniques
Provide technical and statistical input to validation activities (process validation, test method validation, and software validation as applicable)
Support internal, supplier, and regulatory audits by preparing documentation, analyzing data, and responding to audit findings
Contribute to continuous improvement initiatives by identifying process improvements based on statistical and risk-based analyses
Support the development and tracking of Quality and Operations KPIs (i.e., NCPs, Deviations, Inspection data, Facility and Laboratory data)
Support Supplier Qualification maintenance and evaluation
Participate in Design of Experiments and test protocol development and finished reports (i.e., electrical testing related to 60601)
Partner with R&D, Manufacturing, Regulatory Affairs, and Supply Chain teams to integrate appropriate quality documentation practices and risk management principles into product and process decisions
Prepare and present risk and quality data summaries to stakeholders and leadership in a clear and actionable manner
Mentor and provide guidance to junior quality team members on quality subjects, statistical tools and risk management best practices
Ensure quality activities comply with applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and company quality system procedures
Author, review, and approve quality documentation, including reports, qualification and validation documentation, CAPAs, continuous improvement documents, SOPs, risk assessments, and statistical analyses
Support inspection readiness and ongoing compliance with regulatory and customer requirements
Lead and support product and process risk management activities in accordance with ISO 14971, including risk assessment, Failure Mode Effect Analysis, hazard identification, analysis, evaluation, control, and residual risk assessment
Apply statistical tools and methodologies (e.g., Minitab, trend analysis, capability analysis, reliability analysis, hypothesis testing) to evaluate quality and compliance risks
Analyze quality data to identify emerging risks, adverse trends, and opportunities for risk reduction
Support risk-based decision making throughout design, development, manufacturing, and post-market activities
Maintain and update risk management files, ensuring traceability to design inputs, verification/validation, complaints, and CAPA
Support Operations and Manufacturing by creating Control Charts to indicate performance against operational KPIs
Qualification
Required
Bachelor of Science Degree with at least 7 years of experience or demonstrated success within Medical Device Quality Assurance functions
Expertise in understanding and applying principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485
Advanced skills using Microsoft Word and Excel
Ability to independently conduct product or process quality investigations
Ability to interact in internal and external audits and act as a role model for the QA department
Detail and process oriented
Utilize critical thinking skills to problem solve and troubleshoot
Ability to communicate (written and verbal) and interact effectively with all levels of the organization
Good organizational skills and strong attention to detail
Must be able to perform job requirements independently with minimal supervision
Adjusts easily and readily to a fast-paced work environment with changing priorities
Company
Meridian Bioscience Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, rare reagents, specialty biologicals and components.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$9MKey Investors
National Institutes of Health
2022-07-07Acquired
2022-01-31Grant· $2.5M
2021-02-03Grant· $5.5M
Leadership Team
Andy Kitzmiller
Chief Executive Officer
J
Julie Smith
Chief Financial Officer
Recent News
2025-10-14
MarketScreener
2025-10-14
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