QA Associate Engineer - Quality Systems

Software Guidance & Assistance - Cambridge, MA

Full-time - Entry Level

Cambridge, MA

Professional, Scientific, and Technical Services

About the position

The QA Associate Engineer - Quality Systems plays a crucial role within the Quality Systems department, working collaboratively with various teams across the organization. This position is essential in ensuring that the firm's Quality Management System (QMS), Corrective and Preventive Actions (CAPA), and Non-conformance processes are effective and compliant with industry standards. The Associate QA Engineer will support Quality team members in achieving all related business goals, contributing to the overall success of the organization. In this role, the Associate QA Engineer will support the Quality Management System by implementing continuous improvement initiatives and harmonizing the quality system across all sites. Effective collaboration across functions is key, as the engineer will facilitate the completion of essential documents and maintain the Quality Management Systems for functional areas, including Design Controls, Software Development, Risk Management, and the CAPA system. Additionally, the engineer will manage Non-Conforming Material Reports and support root cause analysis, ensuring the implementation of corrective and preventive actions while verifying their effectiveness as required. The Associate QA Engineer will also be responsible for developing, measuring, and monitoring key performance indicators to track the effectiveness of the quality systems. Other duties may be assigned as necessary, making this a dynamic and engaging position within the firm.

Responsibilities

• Support Quality Management System.
• Implement continuous improvement and harmonization of the quality system across all sites.
• Collaborate cross-functionally to facilitate the completion of documents.
• Maintain Quality Management Systems for functional areas including Design Controls, Software, Development, Risk Management, CAPA system, and Non-Conforming Material Reports.
• Support root cause analysis and implementation of corrective and preventive actions and verification of effectiveness of actions as required.
• Develop, measure, and monitor key performance indicators.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree; OR, 5+ years of equivalent related experience.
• Degree in the Sciences, Engineering or Business-related field.
• Experience with IVD or Medical Device Quality Systems.
• Knowledge of standards and regulations pertaining to the IVD and/or Medical Device industry, including FDA QSR 820, ISO13485, ISO15189, CAP/CLIA, & IVD/IVDR.
• Knowledge of CAPA and Root Cause Investigations.
• Knowledge of Good Manufacturing Practices.
• Ability to communicate, interact and influence effectively regarding quality system processes.
• Ability to work in a fast-paced environment with high attention to detail.
• Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint.
• Good communication skills and ability to work effectively as a member of a multidisciplinary team.
• Understanding of HIPAA and importance of privacy of patient data.
• Commitment to the firm's values: patients, innovation, collaboration, and passion.