Director, Device Operational QA — Hybrid Quality Leader

Vertex Pharmaceuticals Inc (US); Boston (MA); On-site; USD 185,000 - 277,000; Full time

Benefits offered by this job

Hybrid work arrangement

Annual bonus and equity awards

Job summary

Vertex Pharmaceuticals Inc. seeks a Director of Device Operational QA to lead and develop the device QA team, ensuring strong quality-system execution and cross-functional collaboration. The role partners with senior Quality leadership on strategic initiatives and risk management.

The position requires deep expertise in device QA, regulatory requirements, and quality improvements, with at least 12+ years of experience and 5+ years in management. Onsite presence in Boston is expected.

Qualifications

• Typically requires 12+ years of relevant work experience and 5 years of supervisory/management experience
• Significant progressive experience in quality assurance, quality systems, or related regulated environment
• Demonstrated experience supporting design control and risk management for medical devices and combination products
• Demonstrated people-management experience including coaching and talent development
• Minimum bachelor’s degree in a scientific, engineering, allied health, or related field; advanced degree preferred

Responsibilities

• Lead and develop the Device Operational QA team with clear priorities and performance expectations
• Provide quality oversight for device operational activities and ensure compliant quality-system processes
• Serve as a quality partner to cross-functional teams supporting device programs and operations
• Lead assessment, resolution, and escalation of complex operational quality issues and risks
• Oversee quality events, deviations, investigations, CAPA, and change controls
• Review and approve device-related design controls and risk management documentation
• Monitor quality performance, trends, and emerging risks; report to leadership
• Maintain audit and inspection readiness for device operations
• Drive continual improvement of QA processes, tools, and ways of working
• Promote risk-based decision-making and a culture of quality across device operations
• Contribute to quality strategy and capability-building with senior leadership
• Ensure timely execution of quality commitments and actions

Skills

Device Operational QA

Quality-system principles

Regulatory & ISO knowledge

Quality risk management

Quality-event management

Audit readiness

Leadership & people management

Cross-functional collaboration

Decision-making & accountability

Communication skills

Education

Bachelor’s degree in science/engineering/related field

Advanced degree preferred

Job description

Vertex Pharmaceuticals Inc. seeks a Director of Device Operational QA to lead and develop the device QA team, ensuring strong quality-system execution and cross-functional collaboration. The role partners with senior Quality leadership on strategic initiatives and risk management.

The position requires deep expertise in device QA, regulatory requirements, and quality improvements, with at least 12+ years of experience and 5+ years in management. Onsite presence in Boston is expected.