Supplier Quality Engineer

Meridian Bioscience Inc.; North Billerica (MA); In loco; USD 100.000 - 130.000; Tempo pieno

Descrizione del lavoro

Meridian Bioscience Inc. is seeking a Supplier Quality Engineer to ensure suppliers meet quality, regulatory, and operational requirements.

You will work with Procurement, Manufacturing, Engineering, and Operations to drive supplier performance, manage quality issues, and ensure the reliability of purchased materials and services. This role includes supplier qualification, monitoring, audits, and continuous improvement to minimize quality risks across the supply chain.

Competenze

• Bachelor’s degree in engineering or related technical discipline.
• 2–5 years of experience in supplier quality or quality engineering.
• Experience in regulated industry such as medical devices preferred.
• Knowledge of ISO 13485, ISO 9001, FDA QSR, or equivalent.
• Experience conducting supplier audits and 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.

Mansioni

• Lead supplier quality activities for assigned suppliers and commodities.
• Monitor supplier performance using quality metrics and KPIs.
• Review supplier quality data, identify trends, and communicate risks to management.
• Support supplier qualification, onboarding, and requalification activities.
• Ensure suppliers meet applicable quality, regulatory, and contractual requirements.
• Plan, conduct, and support supplier audits, including qualification and surveillance.
• Document audit findings and track corrective actions to closure.
• Evaluate supplier responses to audit observations and verify effectiveness.

Conoscenze

CAPA

Nonconformance

Root cause analysis

Risk management

Statistical analysis

Quality tools

Reading drawings

Formazione

Bachelor’s Degree in Engineering or related technical discipline

Strumenti

Minitab

Excel

Descrizione del lavoro

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

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

Job Summary

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).

Cross-Functional 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

Qualifications

• 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
• Experience in regulated industry such as Medical device or other related field, preferred
• 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.
• Travel: 10%

Compensation Range: $100,000–$130,000