Director of Device Quality Operations (Hybrid)

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

Benefits offered by this job

Hybrid-Eligible or On-Site Eligible

Job summary

Vertex is seeking a Director of Device Operational QA to lead a team responsible for executing device quality-system processes and assuring regulatory compliance across operations. You will partner with senior Quality leadership on strategic initiatives and drive continual improvements in quality performance.

The role requires at least 3 days onsite per week at the Boston, MA office and necessitates strong leadership and cross-functional collaboration to ensure timely quality commitments and

Qualifications

• Extensive experience in device operational quality assurance and quality-systems.
• Familiarity with regulatory and ISO requirements for device quality oversight.
• Proven ability to manage complex quality matters and drive improvements.

Responsibilities

• Lead and develop the Device Operational QA team with clear priorities and growth plans.
• Provide quality oversight for device operational activities and ensure QA processes are followed.
• Partner with cross-functional teams on device programs and operations.
• Escalate and drive resolution of complex quality issues and risks.
• Oversee deviations, investigations, CAPAs, and change controls.
• Review device-related quality documentation including design controls and risk management.
• Monitor quality metrics and communicate findings to leadership and stakeholders.
• Maintain audit readiness for device operations and drive process improvements.
• Promote risk-based decision-making and a culture of quality.

Skills

Device QA

Quality systems

Regulatory knowledge

Risk management

Leadership

Cross-functional collaboration

Communication skills

Quality events management

Education

Bachelor’s degree in science/engineering/related field

Advanced degree preferred

Job description

Vertex is seeking a Director of Device Operational QA to lead a team responsible for executing device quality-system processes and assuring regulatory compliance across operations. You will partner with senior Quality leadership on strategic initiatives and drive continual improvements in quality performance.

The role requires at least 3 days onsite per week at the Boston, MA office and necessitates strong leadership and cross-functional collaboration to ensure timely quality commitments and