Director, Device Operational QA

Vertex Inc. • Boston, MA

1d • $184,600 - $277,000 • Hybrid

About The Position

The Director, Device Operational QA leads operational quality assurance activities supporting device programs and operations within Quality. This people-management role oversees device quality-system execution, promotes consistent application of quality standards, and serves as a key quality partner to cross-functional stakeholders. The Director leads and develops the Device Operational QA team, manages quality matters and risks, and drives effective, sustainable quality improvements. The role translates functional quality priorities into operational execution while partnering with senior Quality leadership on strategic initiatives, significant quality risks, and organizational priorities.

The role requires working onsite at the Boston, MA office at least three days per week. It is hybrid-eligible, with the option to work remotely up to two days per week, or to work onsite five days per week with ad hoc flexibility, subject to company policy.

Requirements

• Typically requires 12 or more years of relevant work experience and 5 years of supervisory or management experience, or the equivalent combination of education and 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.
• Bachelor’s degree in a scientific, engineering, allied health, or related field.
• Strong knowledge of Device Operational QA and quality-system principles.
• Knowledge of applicable regulatory and ISO-related requirements for operational quality oversight.
• Knowledge of quality risk management and risk-based decision-making.
• Knowledge of quality-event management, including deviations, nonconformances, investigations, CAPA, and change control.
• Knowledge of quality documentation, record review, and approval practices.
• Knowledge of audit and inspection readiness activities.
• Ability to lead, develop, and motivate teams within a quality organization.
• Ability to assess complex quality matters, identify risks and trends, and appropriately escalate issues.
• Strong cross-functional collaboration, stakeholder management, and influencing skills.
• Ability to prioritize competing demands and drive execution in a complex operational environment.
• Strong written, verbal, presentation, and interpersonal communication skills.
• Demonstrated commitment to quality, compliance, continuous improvement, accountability, and sound judgment.
• Ability to work onsite at the Boston, MA office at least three days per week.

Nice To Haves

• Advanced degree.

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, corrective and preventive actions, and change controls, as applicable.
• Provide direction for review and approval of device-related quality documentation and records, including design controls and risk management.
• Monitor operational quality performance, metrics, trends, and emerging risks; communicate findings and recommendations to Quality leadership and key stakeholders.
• Support and maintain audit and inspection readiness for device operational activities.
• Drive continual improvement of Device Operational QA processes, procedures, tools, and ways of working.
• Promote risk-based decision-making, accountability, collaboration, and a culture of quality across device operations.
• Contribute to functional planning, quality strategy, and capability-building initiatives in partnership with senior Quality leadership.
• Ensure timely execution of quality commitments and appropriate follow-up on actions, decisions, and escalated matters.

Benefits

• Annual bonus eligibility.
• Annual equity awards.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy.
• Matching charitable donations.
• 401(k).
• Some roles may be eligible for overtime pay in accordance with federal and state requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Director