Device Quality Strategy Director

Vertex Inc.; Boston (MA); Hybrid; USD 214,000 - 320,000; Full time

Job summary

Vertex Inc. is seeking a Senior Director of Device Quality to provide strategic quality leadership for device and combination product operations across development, manufacturing, testing, clinical, and post-market activities in the Boston area.

You will define and execute the device QA strategy, oversee CDMOs and suppliers, manage design controls, and serve as Management Representative for the Device QMS. In this role, you will ensure ISO 13485, 21 CFR 820, and ISO 14971 compliance, lead CAPA

Qualifications

• Broad expertise in Device and Combination Product Quality Assurance, QMS, and operational Quality oversight.
• Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
• Demonstrated experience with CDMO/external partner oversight, supplier Quality, testing, audits, and inspection readiness.
• Strong understanding of design controls, design transfer, risk management, manufacturing controls, supplier controls, and product realization.
• Proven experience with CAPA, investigations, deviations, change control, complaints, and quality risk management.
• Demonstrated capability to serve as Management Representative, including QMS performance, management review, compliance oversight, and risk escalation.
• Strong strategic thinking, business acumen, risk-based decision-making, and problem-solving skills.
• Ability to influence senior leaders and drive outcomes in a complex, matrixed organization.
• Demonstrated leadership in cross-functional strategic initiatives.
• Strong people leadership skills with demonstrated ability to develop talent, build organizational capability, and foster Quality ownership.

Responsibilities

• Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.
• Provide Quality oversight of CDMOs, suppliers, testing laboratories, and other external partners, including quality agreements, audits, performance, and risk management.
• Provide Quality oversight of internal design control, design transfer, manufacturing, testing, and product realization activities.
• Serve as Management Representative for the Device QMS, ensuring QMS effectiveness, management review, compliance, and continual improvement.
• Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
• Provide strategic oversight of deviations, investigations, CAPA, change control, complaints, supplier quality, audits, and inspection readiness.
• Establish and monitor Quality metrics, risks, trends, and performance, driving timely escalation and resolution of significant issues.
• Provide Quality leadership for regulatory inspections, notified body audits, product milestones, and launch readiness.
• Partner with senior leaders on enterprise-wide Quality initiatives that improve compliance, operational effectiveness, and business performance.
• Build organizational capability through talent development, coaching, and strong cross-functional leadership.

Skills

Device QA

QMS Oversight

ISO 13485

21 CFR 820

ISO 14971

CAPA

Investigations

Change Control

Regulatory Compliance

Leadership

Cross-functional Leadership

Education

Bachelor's degree in a scientific, allied health, or operations research field

Job description

Vertex Inc. is seeking a Senior Director of Device Quality to provide strategic quality leadership for device and combination product operations across development, manufacturing, testing, clinical, and post-market activities in the Boston area.

You will define and execute the device QA strategy, oversee CDMOs and suppliers, manage design controls, and serve as Management Representative for the Device QMS. In this role, you will ensure ISO 13485, 21 CFR 820, and ISO 14971 compliance, lead CAPA