Director, Device Operational QA

Job title: Director, Device Operational QA

Job Description

General Summary:

The Director, Device Operational QA, is responsible for leading operational quality assurance activities supporting device programs and operations within Quality. This people-management role provides oversight of 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.

This role requires a minimum of 3 days onsite per week at our Boston, MA office.

Key Duties and 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 directions for the review and approval of device-related quality documentation and records that include design controls and risk management, at a minimum.
• 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.

Knowledge and Skills:

• 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.

Education and Experience:

• Typically requires 12+ years of relevant work experience and 5 years of supervisory/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.
• Minimum bachelor’s degree in a scientific, engineering, allied health, or related field; advanced degree preferred.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:

1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition.