Senior QMS & CAPA Specialist — Compliance & Improvement

Hologic, Inc.; Marlborough (MA); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic, Inc. is seeking a senior-level QMS Specialist to act as SME for CAPA, NC, and quality compliance across regulated medical device workstreams.

The role focuses on driving compliant, sustainable QMS improvements, remediation support, and inspection readiness while partnering across cross-functional teams. The candidate will apply knowledge of FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, and other global standards, lead root cause analyses, implement corrective actions, and monitor

Qualifications

• Experience in a regulated medical device environment with QMS
• CAPA, NC, and quality compliance processes experience
• FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, EU MDR, MDSAP familiarity
• Root cause analysis, risk assessment, corrective actions, and effectiveness checks
• Internal and external audits, change control, and data trending
• Audit/inspection readiness including FDA and Notified Body audits
• Quality metrics, dashboards, and data-driven improvement
• Statistical analysis experience preferred
• PLM systems and metric reporting tools experience
• Ability to travel up to 15% (including international)

Responsibilities

• Serve as SME for CAPA, NC, and quality compliance processes
• Lead or support remediation of QMS processes and records
• Prepare regulatory documentation and investigations
• Develop sustainable corrective actions and effectiveness checks
• Manage dashboards, metrics, and quality performance tracking
• Provide executive-level updates and cross-functional leadership
• Lead cross-functional teams across multiple sites and workstreams
• Train, coach, and mentor junior staff
• Support remediation activities in response to audits and inspections

Skills

SME leadership

CAPA & NC ownership

Regulatory compliance

Root cause analysis

Data-driven improvement

Cross-functional collaboration

Executive communication

Training & mentoring

Program management

Detail-oriented

Education

Bachelor’s degree in technical field

Master’s degree in technical field

Tools

Qlik

PowerBI

Agile/PLM systems

Job description

Hologic, Inc. is seeking a senior-level QMS Specialist to act as SME for CAPA, NC, and quality compliance across regulated medical device workstreams.

The role focuses on driving compliant, sustainable QMS improvements, remediation support, and inspection readiness while partnering across cross-functional teams. The candidate will apply knowledge of FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, and other global standards, lead root cause analyses, implement corrective actions, and monitor