Quality & Regulatory Leader, QMS & Compliance

Cytonome; Lexington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Cytonome is seeking an experienced Director of Quality & Regulatory to lead the company’s QMS in Lexington, MA. This role oversees quality systems, regulatory compliance, and cross-functional collaboration with senior management.

The position requires building a quality-focused culture, managing staff, and ensuring product quality and regulatory readiness for US and global registrations.

Qualifications

• 10 years of experience in Quality within an ISO 13485 regulated environment.
• 5 years’ experience in progressive leadership and management.
• Experience in medical device industry.
• Knowledge and experience with ISO 13485, ISO 9001 and 21CFR 820.
• Hands-on self-starter with ability to work both independently and as part of a team.

Responsibilities

• Designated Management Representative, fulfilling ISO standards and Cytonome’s QMS.
• Act as Champion for Quality Best Practices and GDP/GMP continuous improvement.
• Provide Leadership and Guidance of Quality functions by designing and implementing QMS sub-systems.
• Ensure Cytonome remains compliant with local, federal and global regulations and standards.
• Promote Quality and QMS awareness throughout the organization.
• Oversee CAPA, non-conforming materials, supplier quality, audits and regulatory reporting.
• Manage external auditors and regulatory agency on-site audits and follow-ups.
• Collaborate on design controls and change control systems with cross-functional teams.
• Establish and maintain product quality, safety and reliability for US/global registrations.
• Lead cost-saving initiatives and continuous improvement to support financial objectives.

Skills

Quality leadership

Regulatory compliance

Internal audits

Documentation control

CAPA processes

Continuous improvement

Education

Bachelor’s degree in engineering or scientific discipline

Master’s degree preferred

Job description

Cytonome is seeking an experienced Director of Quality & Regulatory to lead the company’s QMS in Lexington, MA. This role oversees quality systems, regulatory compliance, and cross-functional collaboration with senior management.

The position requires building a quality-focused culture, managing staff, and ensuring product quality and regulatory readiness for US and global registrations.