Director of Quality & Regulatory

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.

• 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.);

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

• 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
• 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.