Systems analyst Jobs in Lowell, MA

Position Summary

The Quality Systems Analyst (QSA) will be responsible for coordinating and managing nonconformance activities and deliverables within the quality system. This role will also support other quality system elements including training curriculum management, document analyst responsibilities, and audit participation. The ideal candidate will have a strong background in quality assurance, particularly within the medical device industry, and possess excellent organizational and communication skills. Additionally, the QSA assists in special projects aimed at reducing waste and optimizing resources in quality systems and processes. The QSA interacts with different areas of the organization at a local, regional, and global level to meet the objectives and indirectly leads activities.

Principal Responsibilities

The key areas of responsibilities are :

• Nonconformance processing- lead quality activities such as NC containment, correction, and closure; drive improvement through analysis of trend data
• Coordinate and manage nonconformance reports (NCRs) and related activities.
• Ensure timely investigation, documentation, and resolution of nonconformance issues.
• Work collaboratively with cross-functional teams to identify root causes and implement corrective and preventive actions (CAPA).
• Monitor and track nonconformance trends and report findings to management.
• Assist in the development, implementation, and maintenance of the quality management system (QMS) in compliance with regulatory requirements (e.g., FDA, ISO 13485).
• Coordinate and manage the training curriculum for employees, ensuring compliance with quality system requirements.
• Analyze and review quality system documents to ensure accuracy, completeness, and compliance.
• Participate in internal and external audits, providing support and documentation as needed.
• Assist in the preparation and review of audit reports, ensuring timely follow-up on corrective actions.
• Assist in the collection, analysis, and reporting of quality metrics.
• Prepare and distribute regular quality metric reports to management.
• Monitor key performance indicators (KPIs) to identify trends and areas for improvement.
• other duties as assigned.

Education / Experience Requirements

Specialized Skills / Other Requirements

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