Bachelor’s Degree in Engineering, Manufacturing Engineering, or related technical discipline
0 to 3 years of experience in Production Quality or related function
Preferred experience in regulated industries like Medical Devices
Basic knowledge of Quality Management Systems (QMS) such as ISO 13485 and FDA regulations
Understanding of manufacturing processes and quality engineering principles
Familiarity with nonconformance management and CAPA processes
Proficiency in Microsoft Office applications
Responsibilities
Support daily quality activities in manufacturing operations
Review production records for compliance and accuracy
Participate in product inspections and readiness activities
Assist in investigating nonconforming materials and products
Monitor quality metrics and implement corrective actions
Collaborate with cross-functional teams to resolve quality issues
Support investigations of deviations and production quality events
Participate in root cause analysis and CAPA development
Maintain compliance with quality system requirements
Assist in audits and regulatory inspections
Contribute to continuous improvement projects
Benefits
Collaborative work environment
Opportunities for professional development
Engagement in continuous improvement initiatives
Exposure to regulated industry practices
Cross-functional teamwork opportunities
Full Job Description
Job Summary
The Associate Production Quality Engineer supports quality assurance activities within manufacturing operations and supplier quality management processes. Working under the guidance of the Senior Quality Assurance Engineer, this role helps ensure that products are manufactured and released in compliance with applicable regulatory requirements, quality standards, and company procedures. The Associate Production Quality Engineer contributes to production quality oversight, supplier performance monitoring, nonconformance investigations, and continuous improvement initiatives to support operational excellence and product quality.
Key Duties
Production Quality Support
Support daily quality activities related to manufacturing operations and production processes.
Review production records and quality documentation for completeness, accuracy, and compliance with established procedures.
Participate in manufacturing process reviews, product inspections, and production readiness activities.
Assist with the evaluation, investigation, and disposition of nonconforming materials and products.
Monitor quality-related production metrics and support implementation of corrective actions when required.
Collaborate with Production, Engineering, and Operations teams to address quality issues and improve manufacturing performance.
Nonconformance and CAPA Activities
Support investigations of deviations, nonconformances, and production quality events.
Participate in root cause analysis using quality problem-solving methodologies such as 5-Why, Fishbone Analysis, and Risk Assessments.
Assist in the development, implementation, and monitoring of Corrective and Preventive Actions (CAPAs).
Verify completion and effectiveness of corrective actions within established timelines.
Supplier Quality Support
Collaborate wiith Supplier Quality Engineer to support resolution of supplier-related quality issues impacting manufacturing operations.
Escalate supplier-related nonconformances to Supplier Quality Engineer for investigation and resolution.
Assist in the review of supplier documentation, quality records, and corrective action responses.
Collaborate with Supply Chain and Supplier Quality personnel to ensure timely resolution of supplier quality concerns
Quality Systems and Compliance
Maintain compliance with company quality system requirements and applicable regulatory standards.
Assist in the creation, revision, and maintenance of quality procedures, work instructions, and records.
Support internal audits, external audits, customer audits, and regulatory inspections.
Ensure quality documentation is completed accurately and maintained according to record retention requirements.
Continuous Improvement
Participate in continuous improvement projects focused on enhancing product quality, process efficiency, and compliance.
Analyze quality data and prepare routine reports and trending analyses.
Support implementation of risk management and process improvement initiatives.
Contribute to a culture of quality, compliance, and operational excellence.
Qualifications
Bachelor’ Degree in Engineering, Manufacturing Enginering, or related technical discipline
0 to 3 years of experience in Productio Quality, Quality Engineering, Manufacturing Quality or related function
Experience in regulated industry such as Medical device or other related field, preferred
Basic knowledge of Quality Management Systems (QMS), including ISO 13485, ISO 9001, FDA 21 CFR Part 820, or equivalent regulations.
Understanding of manufacturing processes and quality engineering principles.
Familiarity with nonconformance management, CAPA processes, and root cause analysis techniques.
Knowledge of Good Documentation Practices (GDP).
Proficiency in Microsoft Office applications.
Strong analytical, organizational, and communication skills.
Ability to work effectively in a cross-functional team environment.
Travel: 5%
Compensation Range: $85,000–$110,000
About Meridian Bioscience, Inc
Meridian Bioscience, Inc. is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We are headquartered in Cincinnati, OH.
