Senior Director of Quality

About the role

We are looking for an experienced Senior Director of Quality to provide strategic leadership across quality systems, compliance, and operational excellence within a growing medical device organization. You will partner with cross‑functional teams to ensure product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.

Key responsibilities

• Lead company‑wide quality systems and compliance activities.
• Drive continuous‑improvement initiatives focused on product quality, operational performance, and customer satisfaction.
• Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to support business objectives.
• Ensure compliance with applicable regulatory requirements, industry standards, and internal procedures.
• Oversee internal and external audits, inspections, and quality‑related assessments.
• Manage quality metrics, management reviews, and strategic quality planning.
• Support risk management, CAPA, complaint handling, non‑conformance, and change‑control processes.
• Develop and mentor high‑performing quality teams and build organizational capability.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline (advanced degree preferred).
• Progressive quality leadership experience in medical devices, life sciences, or other highly regulated industries.
• Strong knowledge of quality management systems, regulatory requirements, and industry best practices.
• Proven ability to lead teams and influence stakeholders across multiple functions.
• Demonstrated success managing complex projects and driving improvements.
• Excellent communication, leadership, and problem‑solving skills.

Required skills

• Quality management systems
• Regulatory compliance
• Risk management
• CAPA (Corrective and Preventive Action)
• Complaint handling
• Non‑conformance management
• Change‑control processes

What we offer

• Opportunity to influence quality strategy and organizational performance.
• Collaborative, mission‑driven environment.
• Competitive compensation and comprehensive benefits.
• Professional growth and leadership development opportunities.