Quality & Regulatory Excellence Director

STgenetics; Lexington (MA); On-site; USD 150,000 - 230,000; Full time

Job summary

Cytonome is seeking an experienced Director of Quality & Regulatory to lead the QMS, drive regulatory compliance, and oversee quality systems across the organization from Lexington, MA. This role focuses on ensuring product quality, reliability, and regulatory readiness for US and global registrations.

Responsibilities include managing CAPA, audits, supplier quality, and cross-functional quality initiatives while fostering Cytonome’s cultural values and quality policy.

Qualifications

• Bachelor’s degree in engineering or scientific discipline; master’s preferred.
• 10 years of quality experience in an ISO 13485 regulated environment.
• Experience in medical device industry and QMS/ISO standards.

Responsibilities

• Designated Management Representative for ISO standards and QMS.
• Lead Quality functions and sub-systems across the organization.
• Ensure compliance with local, federal, and global regulations and standards.
• Oversee non-conforming material reporting, CAPA, complaints, validations, and document control processes.
• Manage internal audits and external audits with certification bodies and regulators.
• Collaborate cross-functionally to ensure design & change controls are effective.

Skills

Quality leadership

Regulatory compliance

ISO 13485

GMP

Cross-functional leadership

Education

Bachelor’s Degree in Engineering/Science

Master’s degree preferred

Tools

CAPA

Document control

Internal audits

Regulatory coordination

Job description

Cytonome is seeking an experienced Director of Quality & Regulatory to lead the QMS, drive regulatory compliance, and oversee quality systems across the organization from Lexington, MA. This role focuses on ensuring product quality, reliability, and regulatory readiness for US and global registrations.

Responsibilities include managing CAPA, audits, supplier quality, and cross-functional quality initiatives while fostering Cytonome’s cultural values and quality policy.