Manufacturing Quality Engineer, Associate

Meridian Bioscience International Limited; North Billerica (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Meridian Bioscience International Limited in Massachusetts is seeking an Associate Production Quality Engineer to support quality assurance within manufacturing and supplier quality processes. Working under the Senior QA Engineer, you will help ensure products are manufactured and released in compliance with regulatory requirements and company procedures.

You will contribute to production quality oversight, supplier performance monitoring, investigations of nonconformances, CAPA activities, and

Qualifications

• Bachelor's degree in a technical field (Engineering, Manufacturing Engineering or related).
• 0–3 years of experience in Production Quality, Quality Engineering, Manufacturing Quality or related function.
• Experience in regulated industries such as medical devices preferred.
• Knowledge of Quality Management Systems (QMS) and regulatory standards (ISO 13485, ISO 9001, FDA 21 CFR Part 820).
• Understanding of manufacturing processes and quality engineering principles.
• Familiarity with nonconformance management, CAPA processes and root cause analysis.
• Proficiency in Microsoft Office; strong analytical, organizational and communication skills.

Responsibilities

• Support quality activities in manufacturing operations and production processes.
• Review production records and quality documentation for accuracy and compliance.
• Participate in manufacturing process reviews, product inspections and readiness activities.
• Assist in nonconformance investigations, CAPA development and action verification.
• Monitor quality metrics and assist with corrective actions.
• Collaborate with cross-functional teams to address quality issues and improve manufacturing performance.

Education

Bachelor's Degree in Engineering, Manufacturing Engineering, or related technical discipline

Tools

Quality Management Systems (QMS) / ISO 13485 / ISO 9001 / FDA 21 CFR Part 820

Job description

Meridian Bioscience International Limited in Massachusetts is seeking an Associate Production Quality Engineer to support quality assurance within manufacturing and supplier quality processes. Working under the Senior QA Engineer, you will help ensure products are manufactured and released in compliance with regulatory requirements and company procedures.

You will contribute to production quality oversight, supplier performance monitoring, investigations of nonconformances, CAPA activities, and