Hiring: Director of Quality & Regulatory Company: Cytonome Location: Lexington, MA Job Posted Time: 2026-09-12 10:57:13 Employment Type: Full-time / On-site Target Skills & Keywords : Regulatory Compliance About the job Experience: •10 years of experience in Quality within an ISO 13485 regulated environment •5 years’ experience in progressive leadership and management Required Skills: •Designated Management Representative, fulfilling the requirements of applicable ISO standards and Cytonome’s QMS. •Act as Champion for Quality Best Practices and GDP/GMP continuous improvement efforts. •Provide Leadership and Guidance of Quality functions by designing and implementing appropriate QMS sub-systems and programs to facilitate Cytonome’s business infrastructure. •Ensure Cytonome remains compliant with local, federal and global regulations and standards. •Promote Quality and QMS awareness throughout the organization. •Implement, oversee and maintain NCMR (Non-Conforming Material Reporting), CAPA (Corrective and Preventative Actions), complaints, validations, s/w validations, inspections,document control, training, internal audit, management review, supplier quality and problem resolution processes; and the tracking & reporting of associated metrics. •Conduct Internal process Audits of the QMS and assure timely corrective actions. •Manage external Auditors, certification bodies and Regulatory Agencies on-site audits and follow-ups. Qualifications: •Knowledge and experience with external standards: ISO 13485, ISO 9001 and 21CFR 820, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints. •Excellent interpersonal and communication skills and sound organizational skills •Must be able to multi‐task and evaluate priorities •“Hands-on” self-starter with ability to work both independently and as part of a team. •Cytonome excels in creating a workplace where imaginative thinkers can participate in a stimulating entrepreneurial environment and contribute to a highly motivated, success-driven team. Cytonome Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!