Work Location: Middlesex County, Massachusetts

Summary:

The Quality Systems Specialist is responsible for managing and improving the integrated management system, leading quality initiatives, and supporting regulatory compliance. This hands-on role involves regulatory reporting, technical problem-solving, and strategic planning for the Quality department. The position collaborates with program teams and functional groups to ensure successful product launches and ongoing support.

Responsibilities:

• Lead and support the transition and ongoing management of the Quality Management System, including document approval, review, and change processes.
• Develop and deliver training materials for system users and serve as the system administrator, maintaining user lists and communicating system updates.
• Investigate customer complaints by identifying problems, conducting root cause analysis, and implementing corrective actions.
• Communicate with customers regarding ongoing complaint investigations and provide timely updates.
• Collect and analyze key quality metrics to support continuous improvement initiatives.
• Collaborate with internal teams on quality-related matters, including investigations, calibration, and corrective actions.
• Support and participate in audits to ensure compliance with procedures and drive performance improvements.
• Perform additional duties as assigned and maintain core working hours from 5:00 AM to 2:00 PM (ET).

Qualifications:

• Bachelor’s degree with 3-5 years of relevant experience.
• Knowledge of Quality and Environmental Management System standards (such as ISO 9001).
• Experience with quality management documentation systems.
• Direct experience working with internal customers and supporting audits.
• Strong problem-solving skills, especially in customer-related issues.
• Ability to gather data, complete information, and prepare reports.
• Capable of multitasking and collaborating across all organizational levels.
• Excellent verbal and written communication skills; fluency in English required.
• Physically able to lift up to 50 lbs. occasionally and perform active tasks (standing, bending, reaching, etc.).
• Advanced knowledge of ISO 9001 standard preferred.
• Experience working in a global, multi-site environment preferred.
• Background in cGMP/cGDP environments preferred.
• Advanced proficiency with Microsoft Office suite (Word, Excel, Access, PowerPoint) preferred.

Published Category: Quality & Validation