Production Quality Engineer - CAPA & Improvement

Meridian Bioscience Inc.; North Billerica (MA); Sur place; USD 85 000 - 110 000; Plein temps

Résumé du poste

Meridian Bioscience Inc. is seeking an Associate Production Quality Engineer to support quality assurance activities within manufacturing operations and supplier quality management.

Working under the guidance of the Senior Quality Assurance Engineer, this role helps ensure products are manufactured and released in compliance with applicable regulatory requirements, quality standards, and company procedures.

Qualifications

• Bachelor’s Degree in Engineering, Manufacturing Engineering, or related technical discipline is required.
• 0 to 3 years of experience in Production Quality, Quality Engineering, Manufacturing Quality or related function.
• Experience in regulated industry such as Medical device or related field is preferred.
• Familiarity with 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.
• Knowledge of 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%

Responsabilités

• 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 evaluation, investigation, and disposition of nonconforming materials and products.
• Monitor quality-related production metrics and support corrective actions when required.
• Collaborate with Production, Engineering, and Operations teams to address quality issues and improve manufacturing performance.
• Support investigations of deviations, nonconformances, and production quality events.
• Participate in root cause analysis using quality problem-solving methodologies.
• Assist in development, implementation, and monitoring of CAPAs.
• Verify completion and effectiveness of corrective actions within established timelines.
• Collaborate with Supplier Quality Engineer to support resolution of supplier-related quality issues.
• Escalate supplier-related nonconformances for investigation and resolution.
• Assist in 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
• Maintain compliance with quality system requirements and applicable regulatory standards.
• Assist in creation, revision, and maintenance of quality procedures, work instructions, and records.
• Support internal, external, customer audits and regulatory inspections.
• Ensure quality documentation is completed accurately and maintained according to retention requirements.
• 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 risk management and process improvement initiatives.
• Contribute to a culture of quality, compliance, and operational excellence.

Connaissances

Analytical skills

Communication

Cross-functional teamwork

Regulatory industry knowledge

Formation

Bachelor’s Degree in Engineering / related technical discipline

Outils

Quality Management Systems (QMS)

Microsoft Office

Description du poste

Meridian Bioscience Inc. is seeking an Associate Production Quality Engineer to support quality assurance activities within manufacturing operations and supplier quality management.

Working under the guidance of the Senior Quality Assurance Engineer, this role helps ensure products are manufactured and released in compliance with applicable regulatory requirements, quality standards, and company procedures.