Quality Engineer

Job Title: Quality Engineer

Location: Cambridge, MA

Industry: Medical Device / Pharmaceutical

We are seeking a highly motivated and detail-oriented Quality Engineer to support quality assurance and compliance activities within a GMP-regulated Medical Device and Pharmaceutical manufacturing environment. The Quality Engineer will be responsible for maintaining quality systems, supporting investigations, driving continuous improvement initiatives, and ensuring compliance with FDA, cGMP, ISO 13485, and company quality standards. The ideal candidate will work cross-functionally with Manufacturing, Validation, Engineering, and Regulatory teams to ensure product quality and patient safety.

• Support Quality Management System (QMS) activities and ensure compliance with FDA, cGMP, and ISO 13485 requirements.
• Review and approve deviations, non-conformances, CAPAs, and change controls.
• Conduct root cause investigations and implement corrective and preventive actions.
• Support internal, customer, and regulatory audits and inspections.
• Review manufacturing, validation, and quality documentation for compliance.
• Perform risk assessments and quality impact evaluations.
• Monitor quality metrics and identify opportunities for continuous improvement.
• Support supplier quality activities, including qualification and performance monitoring.
• Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle.
• Assist in process validation, equipment qualification, and product quality improvement initiatives.

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related field.
• 3+ years of Quality Engineering experience in Medical Device, Pharmaceutical, or Biotechnology industries.
• Knowledge of FDA regulations, cGMP, ISO 13485, and quality systems.
• Experience with CAPA, deviations, change control, and investigations.
• Strong problem-solving and root cause analysis skills.
• Excellent communication and documentation skills.