VP of Quality Full Time NEW

This is a senior leadership role responsible for defining and scaling a world-class quality organization within a fast-growing, regulated medical technology environment. The role combines strategic ownership of regulatory certification with hands-on leadership in building and operating a robust Quality Management System (QMS). You will play a critical part in ensuring product safety, compliance, and reliability across hardware, software, and system-level products. Working closely with engineering, product, and operations teams, you will embed quality deeply into product development and supply chain processes. The position requires strong expertise in ISO 13485 and medical device regulations, alongside the ability to lead cross-functional transformation. This is a high-impact opportunity to shape both the quality culture and operational backbone of an organization delivering technology-enabled care solutions.

Accountabilities

The VP of Quality will lead the end-to-end quality strategy, ensuring compliance, scalability, and operational excellence across the organization:

• Own the ISO 13485 certification roadmap, including gap assessment, QMS design, implementation, and successful audit completion, while maintaining ongoing compliance through surveillance cycles.
• Architect and scale the Quality Management System within a PLM-integrated environment, embedding quality processes directly into engineering workflows and ensuring traceability across requirements, design, validation, and risk artifacts.
• Establish and continuously improve core QMS processes including document control, CAPA, internal audits, complaint handling, risk management, and post-market surveillance.
• Define and enforce quality standards across hardware, software, and electromechanical systems, ensuring compliance with ISO 14971, IEC 62304, and FDA 21 CFR Part 820.
• Build and lead supplier and manufacturing quality systems, including audits, qualification frameworks, incoming inspection programs, and Six Sigma-driven continuous improvement initiatives.
• Drive customer-facing quality resolution processes, acting as escalation point for product quality issues and ensuring effective root cause analysis and corrective actions.
• Build and mentor a high-performing quality organization, fostering a culture of accountability, early issue detection, and cross-functional ownership of quality outcomes.

Requirements

This role requires deep expertise in medical device quality systems and proven leadership in building scalable compliance frameworks:

• 10+ years of progressive experience in quality leadership within the medical device industry, with strong exposure to regulated environments and enterprise-scale products.
• Demonstrated hands-on ownership or co-ownership of multiple ISO 13485 certifications, with clear responsibility for QMS design, audit readiness, and execution.
• Proven experience building or significantly transforming a QMS from the ground up, ideally within a PLM-integrated engineering environment.
• Strong understanding of regulatory frameworks including ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR Part 820.
• Experience spanning hardware, software, systems, and supplier quality, with the ability to unify these disciplines under a single quality strategy.
• Track record of building and leading quality teams, including hiring, mentoring, and developing talent in high-growth environments.
• Strong communication and stakeholder management skills, with the ability to influence engineering, executive, and regulatory audiences effectively.

Benefits

• Competitive executive compensation: $260,000-$300,000 base salary
• Equity participation in a high-growth organization
• Comprehensive health coverage including medical, dental, and vision plans
• Flexible paid time off (PTO)
• Remote-first flexibility across Canada and the US (NYC preferred)
• Opportunity to build and define a foundational quality organization from the ground up
• Exposure to cutting-edge medical technology and regulated product development environments.

How Jobgether Works

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role’s core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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