Director, Device Quality Operations

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

Job summary

Vertex Pharmaceuticals is seeking a Director of Device Operational QA to lead and develop the Device Operational QA team in support of device programs and operations within Quality. The role requires close partnership with senior Quality leadership on strategic initiatives and risk management, with a minimum of three onsite days per week at the Boston, MA office.

The candidate will drive quality-system execution, manage risks, and advance continuous improvements across device operations,

Qualifications

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

Responsibilities

• Lead, coach, and develop the Device Operational QA team; establish clear priorities, performance expectations, and development plans.
• Provide quality oversight for device operational activities and ensure consistent execution of applicable quality-system processes and standards.
• Serve as a key quality partner to cross-functional teams supporting device programs and operations.
• Lead assessment, resolution, communication, and escalation of complex operational quality issues and risks.
• Ensure appropriate oversight of quality events, including deviations, nonconformances, investigations, CAPA, and change control.

Skills

Device Operational QA

Quality-system principles

Regulatory knowledge

Risk management

Audit readiness

Cross-functional collaboration

Leadership

Change control

Education

Bachelor’s degree in science/engineering/health field

Advanced degree preferred

Job description

Vertex Pharmaceuticals is seeking a Director of Device Operational QA to lead and develop the Device Operational QA team in support of device programs and operations within Quality. The role requires close partnership with senior Quality leadership on strategic initiatives and risk management, with a minimum of three onsite days per week at the Boston, MA office.

The candidate will drive quality-system execution, manage risks, and advance continuous improvements across device operations,