Director, Device Operational QA (Medical Devices)

Location: Boston, MA, United States. Minimum 3 days onsite per week; hybrid work allows up to 2 remote days per week, or employees may choose a fully onsite schedule.

Base salary: $184,600–$277,000 per year, plus eligibility for annual bonus and equity awards.

Company

Vertex is a global biotechnology company investing in scientific innovation and developing outcomes for patients.

What you will do

• Lead, coach, and develop the Device Operational QA team, including priorities, performance expectations, and development plans.
• Provide quality oversight for device operations and consistent execution of quality-system processes and standards.
• Partner with cross-functional stakeholders and senior Quality leadership on strategic initiatives, quality risks, and organizational priorities.
• Assess, resolve, communicate, and escalate complex operational quality issues and risks.
• Oversee deviations, nonconformances, investigations, CAPA, change controls, and review and approval of device quality documentation and records.
• Monitor quality metrics, trends, and emerging risks; maintain audit and inspection readiness and drive continual process improvement.

Requirements

• 12+ years of relevant work experience and 5 years of supervisory or management experience, or an equivalent combination of education and experience.
• Progressive experience in quality assurance, quality systems, operational quality, manufacturing quality, or a related regulated environment.
• Experience supporting design control and risk management activities for medical devices and combination products.
• People-management experience covering coaching, performance management, talent development, and team leadership.
• Bachelor’s degree in a scientific, engineering, allied health, or related field.
• Knowledge of Device Operational QA, quality-system principles, applicable regulatory and ISO requirements, risk management, quality-event management, quality documentation, and audit and inspection readiness.
• Ability to assess complex quality matters, identify risks and trends, escalate issues, prioritize competing demands, and drive execution in a complex operational environment.
• Strong cross-functional collaboration, stakeholder management, influencing, written, verbal, presentation, and interpersonal communication skills.
• Demonstrated commitment to quality, compliance, continuous improvement, accountability, and sound judgment.

Nice to have

• Advanced degree.

Culture & Benefits

• Hybrid or onsite work through Vertex’s Flex program; hybrid employees may work remotely up to two days per week.
• Medical, dental, and vision benefits, generous paid time off, and week-long summer and winter company shutdowns.
• Educational assistance, student loan repayment, commuting subsidy, matching charitable donations, and 401(k).
• Continuous learning focused on advances in AI, technology, automation, and industry trends.
• Inclusive workplace committed to equal employment opportunity, nondiscrimination, and reasonable accommodations.