Director of Quality & Regulatory Compliance - Med Devices

Agile Search Inc.; Littleton (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Agile Search Inc. seeks a Director of Quality Assurance and Regulatory Compliance to lead the QA/RA chapter for a PE-backed medical optics company.

You will oversee QMS, audits, and regulatory compliance across multiple sites, ensuring alignment with FDA, ISO, ITAR requirements and industry best practices. You will drive continuous improvement, mentor the QA/RA team, and partner with cross-functional leaders to meet product goals, risk management, and regulatory milestones.

Qualifications

• Lead QA/RA strategy, audits, inspections, CAPA programs.
• Ensure QMS compliance with FDA, ISO, ITAR and related regs.
• Develop and implement quality/regulatory policies and procedures.
• Mentor and develop QA/RA talent across the organization.
• Experience with international registration regulations is a plus.

Responsibilities

• Lead QA/RA strategy and CAPA programs across sites.
• Ensure QMS alignment with FDA, ISO and other regs.
• Oversee internal audits, supplier audits, inspections, and training.
• Support NPI/transfer programs to meet DFMA/DFT goals.
• Interface with customers on quality plans and regulatory requirements.

Skills

Leadership

Quality Assurance

Regulatory Compliance

QMS

Audit Management

Education

Bachelor's degree in engineering

Master's degree preferred

Job description

Agile Search Inc. seeks a Director of Quality Assurance and Regulatory Compliance to lead the QA/RA chapter for a PE-backed medical optics company.

You will oversee QMS, audits, and regulatory compliance across multiple sites, ensuring alignment with FDA, ISO, ITAR requirements and industry best practices. You will drive continuous improvement, mentor the QA/RA team, and partner with cross-functional leaders to meet product goals, risk management, and regulatory milestones.