Sr. QA Engineer, CAPA

About the Job

The Sr QA Engineer (CAPA) plays a critical role in maintaining and improving Foundation Medicine’s quality systems. The role conducts day to day administration of the CAPA process, coordinating the review, documentation and retention of quality records. The Sr QA Engineer, CAPA exercises considerable latitude to prioritize daily activities in a fast-paced environment, monitoring for timely completion of tasks and escalating any potential risks to ensure timely completion of CAPA deliverables. The position coordinates a variety of related tasks, assuming different activities when priorities change and interacting with all departments within Foundation Medicine to support the effectiveness of the CAPA Quality System.

Regular onsite work at a designated Foundation Medicine location is an essential function of this role.

The Sr QA Engineer (CAPA) is an experienced professional with wide-ranging skillsets to assist and support with the CAPA System at Foundation Medicine. The role will report to the Quality Assurance CAPA manager and will conduct day to day administration of the CAPA process, coordinate the review, documentation and retention of quality records. The Sr QA Engineer, CAPA will exercise considerable latitude to prioritize daily activities in a fast-paced environment, monitor for timely completion of tasks and escalate any potential risks to ensure timely completion of CAPA deliverables. The desired candidate is able to coordinate a variety of related tasks, assume different activities when priorities change and interact with all departments within Foundation Medicine to support the effectiveness of the CAPA Quality System.

Key Responsibilities

• Develop and maintain an effective corrective and preventive action program.
• Monitor CAPA phases and associated due dates to ensure timely progression and closure.
• Facilitate cross-functional root cause analysis using tools like 5 Whys, Fishbone, and FMEA.
• Provide technical writing guidance and ensure documentation is compliant with GxP, FDA, CLIA, CAP, ISO 13485, and other applicable standards.
• Facilitate the CAPA Review Board (CRB), including preparation of materials, coordination of meetings, and documentation of decisions.
• Monitor CAPA effectiveness and ensure timely follow-up.
• Support audits and inspections by providing CAPA-related documentation and responses.
• Collaborate with stakeholders in Operations, R&D, Regulatory Affairs, and Clinical teams.
• Identify trends and systemic issues through data analysis and recommend process improvements.
• Assist with reporting Key Performance Indictors (KPIs).
• Other duties as assigned.

Qualifications :

Basic Qualifications :

Preferred Qualifications :

The expected salary range for this position based on the primary location of Boston, MA is $100,320 - $125,400 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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