Quality and Compliance Lead in Kittery, Maine

Quality Systems And Compliance

Alexander Technology Group is looking for a Quality Systems and Compliance to lead, develop, maintain, and improve the company's Quality Management System (QMS). This is an excellent opportunity for someone who enjoys building processes, driving continuous improvement, and making a meaningful impact in a growing organization.

Responsibilities

• Own and continuously improve key Quality Management System (QMS) processes, including CAPA, document control, change control, training, internal audits, complaints, and nonconformances.
• Manage internal audit programs and support supplier, customer, and regulatory audits.
• Ensure compliance with FDA regulations, ISO 13485, and other applicable quality standards.
• Support inspection readiness and maintain quality documentation and metrics.
• Identify compliance risks and lead continuous improvement initiatives across the QMS.
• Support quality reporting, management reviews, and corrective actions.

Qualifications

• 7+ years of experience in Quality Systems, Quality Assurance, or Compliance within a regulated medical device, pharmaceutical, biotech, or combination product environment.
• Experience managing quality system processes and supporting FDA and ISO audits.
• Strong knowledge of FDA Quality System Regulations (QSR) and quality management principles.
• Experience with electronic QMS platforms, CAPA, root cause investigations, document control, and quality metrics.
• Excellent organizational, communication, and cross-functional leadership skills.
• Startup or high-growth company experience is a plus.

If interested, please send resume to