Associate Production Quality Engineer: Quality & Compliance

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

Job summary

Meridian Bioscience International Limited is seeking an Associate Production Quality Engineer to support QA activities within manufacturing and supplier quality processes. You will work under the Senior QA Engineer to ensure product releases meet regulatory standards and quality criteria.

Responsibilities include supporting daily quality tasks, reviewing records, and assisting with CAPA investigations and continuous improvement.

Qualifications

• Bachelor's Degree in Engineering or related technical discipline.
• 0 to 3 years of experience in Production Quality, Quality Engineering, Manufacturing Quality or related function.
• Experience in regulated industries such as Medical device or related field preferred.
• Knowledge of Quality Management Systems (QMS) incl. ISO 13485, ISO 9001, FDA 21 CFR Part 820 or equivalent.
• Understanding of manufacturing processes and quality engineering principles.
• Familiarity with nonconformance management, CAPA processes, and root cause analysis techniques.
• Knowledge of Good Documentation Practices (GDP).
• Proficiency in Microsoft Office applications.
• Strong analytical, organizational, and communication skills.
• Ability to work effectively in a cross-functional team environment.
• Travel: 5%

Responsibilities

• Support daily quality activities related to manufacturing operations and production processes.
• Review production records and quality documentation for completeness, accuracy, and compliance.
• Participate in manufacturing process reviews, product inspections, and production readiness activities.
• Assist with evaluation, investigation, and disposition of nonconforming materials and products.
• Monitor quality-related production metrics and support corrective actions.
• Collaborate with Production, Engineering, and Operations to address quality issues.

Skills

Analytical skills

Organizational skills

Communication skills

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Tools

Microsoft Office

Job description

Meridian Bioscience International Limited is seeking an Associate Production Quality Engineer to support QA activities within manufacturing and supplier quality processes. You will work under the Senior QA Engineer to ensure product releases meet regulatory standards and quality criteria.

Responsibilities include supporting daily quality tasks, reviewing records, and assisting with CAPA investigations and continuous improvement.