Supplier Quality Engineer

Meridian Bioscience•North Billerica, MA

About The Position

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets, and distributes diagnostic products. The Supplier Quality Engineer ensures that suppliers consistently meet the organization’s quality, regulatory, and operational requirements. Reporting to the Senior Quality Assurance Engineer, the role partners with suppliers and 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 position supports supplier qualification, monitoring, auditing, risk management, and continuous improvement to minimize quality risks throughout the supply chain. The role also supports sourcing parts, components, and processes associated with supplier activities. Travel to supplier sites may be required, with travel listed at 10%. The compensation range is $100,000–$130,000.

Requirements

Bachelor’s degree in Engineering, Manufacturing Engineering, or a related technical discipline.
2 to 5 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a 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, monitoring, and 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.

Nice To Haves

Experience in a regulated industry such as medical devices or a related field.

Responsibilities

Manage supplier quality activities for assigned suppliers and commodities.
Monitor supplier performance using established quality metrics and key performance indicators; review quality data, identify trends, and communicate potential risks to management.
Support supplier qualification, onboarding, and requalification, and ensure suppliers meet applicable quality, regulatory, and contractual requirements.
Plan, conduct, and support supplier qualification, surveillance, and for-cause audits; assess supplier quality systems, manufacturing processes, and compliance.
Document audit findings, track corrective actions through closure, evaluate supplier responses, and verify action effectiveness.
Lead investigations into supplier quality issues involving nonconforming materials, components, and services; coordinate containment and timely resolution.
Facilitate root cause analysis using methods such as 5-Why, Fishbone Analysis, and FMEA; review and approve supplier corrective action reports and verify SCAR effectiveness.
Partner with Procurement and Supply Chain on supplier selection and development; collaborate with Manufacturing, Engineering, and Quality to address production issues related to suppliers.
Participate in product transfers, process changes, and new product introductions involving suppliers; provide quality input on supplier change notifications and risk assessments.
Identify and assess supplier risks affecting product quality, delivery, or compliance; support supplier development and continuous improvement initiatives.
Use statistical analysis and quality tools to support data-based decisions and improve supplier quality systems and supply chain robustness.
Ensure supplier quality activities comply with applicable regulations, 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 developing and revising supplier quality procedures, standards, and work instructions.
Participate in sourcing parts, components, and associated processes.