Senior QA Engineer, MedTech Quality & Compliance

Meridian Bioscience, Inc.; North Billerica (MA); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Target bonus 7%

Job summary

Meridian Bioscience, Inc. is seeking a Senior Quality Assurance Engineer in North Billerica, MA to ensure product quality from design to manufacturing.

You will join the Quality & Regulatory Affairs team, driving risk management, design controls, and CAPA implementation to meet FDA and ISO requirements. You will develop and validate test methods, manage documentation, and support supplier quality, internal and external audits, and continuous quality improvements.

Qualifications

• BS in Engineering or Science required.
• 4+ years OEM medical device manufacturing experience.
• Knowledge of GMP and FDA regulations (21 CFR Part 820).
• ISO 13485 understanding and CAPA experience.
• Proficient with MS Office and SOPs.

Responsibilities

• Provide quality engineering support for design, sourcing and manufacturing.
• Lead risk management and design controls throughout product lifecycle.
• Drive quality system execution to 21 CFR 820 and ISO 13485.
• Develop test methods, inspection procedures, and CAPA activities.
• Audit suppliers and participate in internal/external quality audits.
• Support complaint handling and documentation control.

Skills

GMP knowledge

FDA regulations

Quality systems

Problem solving

Communication

Education

Bachelor of Science in Engineering or Science

Tools

Document management systems

Job description

Meridian Bioscience, Inc. is seeking a Senior Quality Assurance Engineer in North Billerica, MA to ensure product quality from design to manufacturing.

You will join the Quality & Regulatory Affairs team, driving risk management, design controls, and CAPA implementation to meet FDA and ISO requirements. You will develop and validate test methods, manage documentation, and support supplier quality, internal and external audits, and continuous quality improvements.