Director Global CAPA Programs (Medtech)

TL;DR

Director Global CAPA Programs (Medtech): Leading global CAPA continuous improvement activities to build expertise and simplify processes for faster problem resolution in the medical device sector with an accent on compliance, efficiency, and performance. Focus on upgrading end-to-end CAPA systems, managing complex remediation portfolios, and fostering shared accountability across the organization.

Location: Remote (Must be based in the US)

Salary: $183,000–$210,000 plus 30% annual bonus

Company

hirify.global provides hospitals and life science institutions with products and solutions for intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing.

What you will do

• Lead cross-functional teams to upgrade and improve the performance of the end-to-end CAPA and NC systems.
• Assess system health regarding compliance and efficiency while managing a portfolio of improvement projects.
• Support internal and external audit activities and engage with stakeholders to integrate requirements into the CAPA system.
• Develop and manage personnel, serving as a CAPA coach and conducting training workshops.
• Monitor FDA enforcement priorities and industry changes through participation in professional conferences.

Requirements

• Must be based in the US.
• Master’s Degree in Business Administration, Quality Management, or a related science discipline.
• Minimum 10 years of experience in medical device quality process areas.
• Deep subject matter expertise in CAPA and NC processes and QMS operations.
• Experience with internal/external audits, consent decrees, and remediation activities.
• Proficiency in Microsoft Office Suite and general understanding of reporting tools like Power BI or Crystal Reports.

Nice to have

• Trackwise application experience.
• Certification in quality management such as Six Sigma, CQM, or ISO Lead Auditor.

Culture & Benefits

• Fully remote work arrangement (5 days at home).
• Opportunities for personal and professional development within a diverse global team.
• Competitive compensation package including a significant annual bonus.
• Mission-driven environment focused on making life-saving technology accessible to more people.