Quality Assurance Engineer

Hologic is seeking a Quality Assurance Engineer to support and strengthen Corrective and Preventive Action, CAPA, processes and broader quality assurance operations. This role will partner closely with Quality Management System, QMS, leadership and cross-functional teams to improve CAPA performance, support remediation efforts, build CAPA competency, and help sustain effective quality systems. The ideal candidate brings strong experience in quality assurance within a regulated environment, particularly medical device, IVD, or pharmaceutical, and has demonstrated expertise in CAPA, root cause analysis, quality metrics, audit support, and continuous improvement. Key Responsibilities CAPA System Leadership and Support

Serve as a subject matter expert for CAPA, including root cause analysis, effectiveness checks, and sustainable corrective actions. Coordinate and facilitate CAPA Review Board meetings and related documentation. Own and improve the divisional CAPA toolbox, including training materials, templates, and reference resources. Monitor CAPA system health, conduct daily reviews for escalations, and coordinate with departments to support adequate resourcing. Provide input into global CAPA process improvements and related training content.

Quality Assurance Operations

Support and model Hologic’s quality values while promoting a culture of accountability, compliance, and continuous improvement. Collaborate with junior staff, peers, and cross-functional stakeholders across multiple organizational levels. Assist in the development, implementation, and maintenance of quality assurance procedures, processes, and documentation. Proactively identify opportunities to strengthen QMS processes, including inputs to and outputs from CAPAs. Analyze quality data and trends to identify improvement opportunities and systemic risks. Develop and maintain CAPA and quality metrics, dashboards, and reporting tools. Routinely partner with internal suppliers and stakeholders to review CAPA data, monitoring, and performance.

Audit and Compliance Support

Participate in and support internal and external audits, including FDA inspections, as a CAPA and quality systems subject matter expert. Assist with audit preparation, data collection, and communication with functional areas to support audit readiness and efficiency. Help ensure compliance with applicable FDA regulations, QMSR, ISO 13485, and other relevant global quality standards.

Training and Mentorship

Mentor and coach junior team members in CAPA and quality system fundamentals. Provide consultation and training on CAPA principles, methodologies, and best practices to QMS and cross-functional teams.

Continuous Improvement and Special Projects

Lead or contribute to CAPA-related remediation projects and continuous improvement initiatives. Support data analysis activities to develop key performance indicators across functions. Review open Quality Plans, QPLs, and provide recommendations for updates or improvements.

Qualifications Education

Technical Bachelor’s degree or higher preferred.

3–8 years of experience in the medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems. Experience with Agile or an equivalent Product Lifecycle Management system is beneficial.

Skills and Knowledge

Strong working knowledge of QMSR, ISO 13485, and global quality regulations. Demonstrated ability to lead cross-functional teams and manage multiple workstreams. Excellent technical writing, analytical, and problem-solving skills. Strong interpersonal and communication skills, including the ability to provide executive-level updates and support regulatory documentation. Detail-oriented, highly organized, proactive, and comfortable working in a dynamic environment. Ability to present materials to director-level leadership. Understanding of statistics and statistical analysis.

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