CAPA Quality Systems Specialist - Medical Device

Hologic is seeking a CAPA Facilitator Associate to support our mission of improving women's health through safe, high-quality medical technologies. In this role, you will coordinate and document Corrective and Preventive Actions (CAPA) across biotech and medical device operations, ensuring timely, compliant resolution of quality issues. You will lead root cause analyses, partner with manufacturing, quality, R&D, and regulatory teams, and maintain detailed records in our electronic quality systems. This position offers exposure to cutting-edge diagnostic and imaging technologies, robust training, and opportunities to impact global patient outcomes in a collaborative, inclusive culture.

Responsibilities

• Coordinate and facilitate CAPA investigations for quality issues in biotech and medical device manufacturing
• Perform root cause analysis using structured problem-solving tools and document findings
• Collaborate with quality, manufacturing, R&D, and regulatory teams to define effective corrective and preventive actions
• Track, monitor, and report CAPA status, metrics, and trends to ensure timely closure
• Support internal and external audits by providing CAPA records and objective evidence
• Ensure CAPA activities comply with FDA, ISO 13485, and company quality system requirements
• Maintain accurate, compliant documentation within electronic quality systems (e
• QMS)
• Assist in training teams on CAPA processes, quality procedures, and continuous improvement
• Identify opportunities to improve CAPA effectiveness and standard work
• Support risk management and change control activities related to CAPA actions

Required Skills

• CAPA management
• Root cause analysis
• Quality systems (FDA QSR, ISO 13485)
• Technical writing and documentatione
• QMS software proficiency
• Data analysis and reporting
• Risk management (FMEA)
• Audit support and remediation
• Cross-functional collaboration
• Process improvement/Lean tools