Director of Quality & Regulatory

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 has an immediate opening for an experienced, full-time Director of Quality & Regulatory!

This position is in office in Lexington, MA and does not offer relocation assistance.

The Director of Quality is responsible for the development, maintenance and execution of the Cytonome Quality Management System including, personnel, systems, procedures, and programs to provide assurance to management and stakeholders of the quality, reliability, and compliance of the organization and data outputs. This is both a leadership and technical competence role that includes management and directing the activities of Quality staff, providing Quality oversight across internal and external processes and close collaboration with internal and external stakeholders. Additionally, the Head of Quality will work with Senior Management to establish and align on corporate culture expectations in line with Cytonome values and Quality Policy.

• Drive Quality Management System (QMS) strategies for the company


• Build and manage the Quality Team


• Responsible for driving QMS improvement initiatives in a fiscally responsible manner to meet business needs.

Cytonome was founded in 2009 on the premise of providing advanced solutions for cell purification needs. By developing cutting-edge technologies in cell purification and platform design, Cytonome provides novel solutions for cell therapy, research and industry. With deep engineering expertise in the cytometry field and an expansive intellectual property portfolio, Cytonome aims to develop products that simplify existing workflows and enable leading-edge advances and research.

Job Responsibilities:

• 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.


• Working cross functionally to ensure design & change control systems are effective.


• Establish, maintain and ensure product quality, safety and reliability enabling timely US and global product registrations and licensing.
  Review & approve product labeling & marketing literature for regulatory compliance.


• Manage product vigilance reporting and responses to Certification bodies and Regulatory Agencies.


• Collaborate on cost-saving initiatives and continuous improvement activities to support organizational financial objectives and Cost of Goods Sold (COGS) targets.


• Manage the Quality Team, ensuring the team activities are planned, resources allocated, priorities established, and activities executed.


• Managerial responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.


• Adhere to applicable laws, regulations and Company’s policies, procedures, including quality management (ISO-9001, ISO-13485, FDA QSR, GMP, etc.), environmental, safety and health (OSHA, EPA, DOT, MWRA, etc.);

MINIMUM REQUIREMENTS & EXPERIENCE NECESSARY TO PERFORM POSITION EFFECTIVELY:

Educational Background:

• Bachelor’s Degree in Engineering or Scientific discipline, Master’s degree preferred

Required experience:

• 10 years of experience in Quality within an ISO 13485 regulated environment


• 5 years’ experience in progressive leadership and management

Other Requirements:

• Experience in medical device industry


• Experience in research & development, preferably software enabled hardware and or medical device consumables


• 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


• Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.


• 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 is an equal opportunity employer. The stated policy of the Company prohibits unlawful discrimination on the basis of race, sex, sexual orientation, religion, color, national origin, age, disability, citizenship, pregnancy, veteran status, or other characteristics protected by federal, state, and/or local law.