Supplier Quality Engineer

Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

About Meridian Bioscience

• Meridian Meridian Bioscience 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.
• We are looking for talented and passionate individuals that help drive our vision.

Responsibilities

• The Supplier Quality Engineer is responsible for ensuring that suppliers consistently meet the organization's quality, regulatory, and operational requirements.
• Reporting to the Senior Quality Assurance Engineer, this role partners with suppliers, Procurement, Manufacturing, Engineering, and Operations teams to drive supplier performance, manage supplier-related quality issues, and ensure the quality and reliability of purchased materials, components, and services.
• The Supplier Quality Engineer supports supplier qualification, monitoring, auditing, risk management, and continuous improvement activities to minimize quality risks throughout the supply chain.
• Key Duties Supplier Quality Management Manage supplier quality activities for assigned suppliers and commodities.
• Monitor supplier performance using established quality metrics and key performance indicators (KPIs).
• Review supplier quality data, identify trends, and communicate potential risks to management.
• Support supplier qualification, onboarding, and requalification activities.
• Ensure suppliers meet applicable quality, regulatory, and contractual requirements.
• Supplier Audits and Assessments Plan, conduct, and support supplier audits, including qualification, surveillance, and for-cause audits.
• Assess supplier quality systems, manufacturing processes, and compliance with applicable standards and regulations.
• Document audit findings and track corrective actions through closure.
• Evaluate supplier responses to audit observations and verify effectiveness of implemented actions.
• Supplier Nonconformance Management Lead investigations related to supplier quality issues, including nonconforming materials, components, and services.
• Coordinate containment activities and ensure timely resolution of supplier-related quality events.
• Facilitate root cause analysis using quality methodologies such as 5-Why, Fishbone Analysis, and Failure Mode and Effects Analysis (FMEA).
• Review and approve supplier corrective action reports and monitor implementation progress.
• Verify effectiveness of supplier corrective and preventive actions (SCARs).
• Collaboration Partner with Procurement and Supply Chain teams to support supplier selection and supplier development initiatives.
• Collaborate with Manufacturing, Engineering, and Quality teams to address supplier-related production issues.
• Participate in product transfers, process changes, and new product introduction activities involving suppliers.
• Provide quality input during supplier change notifications and risk assessments.
• Risk Management and Continuous Improvement Identify and assess supplier-related risks that may impact product quality, delivery, or compliance.
• Support supplier development activities aimed at improving quality performance and reducing defects.
• Participate in continuous improvement initiatives to strengthen supplier quality systems and supply chain robustness.
• Utilize statistical analysis and quality tools to drive data-based decision-making.
• Compliance and Quality Systems Ensure supplier quality activities comply with applicable regulations, industry standards, and company quality system requirements.
• Maintain supplier quality records, audit reports, and approved supplier documentation.
• Support internal audits, customer audits, and regulatory inspections involving supplier controls.
• Assist in the development and revision of supplier quality procedures, standards, and work instructions.
• Participate in sourcing parts and components and processes associated

Requirements

• Bachelor’ Degree in Engineering, Manufacturing Enginering, or related technical discipline 2 to 5 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality or related function
• Knowledge of Quality Management Systems, including ISO 13485, ISO 9001, FDA Quality System Regulations, or equivalent standards.
• Experience conducting supplier audits and supplier assessments.
• Understanding of supplier qualification, supplier monitoring, and supplier development processes.
• Strong knowledge of CAPA, nonconformance management, root cause analysis, and risk management methodologies.
• Familiarity with statistical analysis and quality tools.
• Ability to interpret technical drawings, specifications, and manufacturing documentation.
• Strong written and verbal communication skills.
• Excellent problem-solving and project management abilities.
• Willingness to travel to supplier sites as required.

Preferred

• Experience in regulated industry such as Medical device or other related field, preferred

Pay

10% Compensation Range: $100,000–$130,000