Supplier Quality Engineer:Audits, Compliance & Improvement

Meridian Bioscience International Limited; North Billerica (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Meridian Bioscience International Limited is seeking a Supplier Quality Engineer to partner with suppliers and internal teams to ensure quality, regulatory and operational requirements are met across the supply chain. You will drive supplier performance, manage nonconformances, and contribute to continuous improvement programs.

The role covers supplier qualification, audits, risk assessments, CAPA closures, and collaboration with Procurement, Manufacturing and Quality groups to sustain product

Qualifications

• 2 to 5 years of experience in Supplier Quality or related field.
• Experience in regulated industries such as medical devices or related fields preferred.
• Knowledge of Quality Management Systems (ISO 13485, ISO 9001, FDA QSR) or equivalent.

Responsibilities

• Manage supplier quality activities for assigned suppliers and commodities.
• Monitor supplier performance using quality metrics and 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.
• Plan, conduct, and support supplier audits, including qualification and surveillance.
• Assess supplier quality systems, manufacturing processes, and regulatory compliance.
• Document audit findings and track corrective actions through closure.
• Evaluate supplier responses to audit observations and verify effectiveness of actions.
• Lead investigations related to supplier quality issues and coordinate containment.
• Facilitate root cause analysis (5-Why, Fishbone, FMEA) and CAPA actions.
• Review and approve supplier corrective actions and monitor implementation.
• Identify and assess supplier-related risks and support development initiatives.
• Participate in continuous improvement to strengthen supplier quality systems.
• Utilize statistical analysis and quality tools for data-based decisions.
• Maintain supplier quality records and support internal/regulatory audits.

Education

Bachelor’s Degree in Engineering

Job description

Meridian Bioscience International Limited is seeking a Supplier Quality Engineer to partner with suppliers and internal teams to ensure quality, regulatory and operational requirements are met across the supply chain. You will drive supplier performance, manage nonconformances, and contribute to continuous improvement programs.

The role covers supplier qualification, audits, risk assessments, CAPA closures, and collaboration with Procurement, Manufacturing and Quality groups to sustain product