Director, Quality Systems
The position will be the Management Representative and primarily responsible to ensure that a robust and practical Quality Management System is operational at VytronUS. The role of the position will be to develop, implement and improve the VytronUS QMS, ensuring that it complies with 21 CFR Part 820, ISO 13485 as well as other applicable international quality standards for the medical device industry. This position serves as a Quality Representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, and company quality goals and priorities. The position will work with key stakeholders across VytronUS to provide leadership and vision, as well as drive alignment towards our quality objectives. As part of a start-up medical device company, the position must be hands-on, self-starting, team player; have strong leadership and project management skills, problem solving skills, ability to work under minimum supervision, and communicate effectively with all levels of the organization.
Essential Duties and Responsibilities:
• Responsible for implementation, maintenance and improvements to the VytronUS Quality Management System and reporting on performance of QMS
to VytronUS Leadership Team and dissemination throughout the organization.
• Establishes and builds relationships with internal stakeholders and external vendors to support business initiatives and milestones.
• Responsible for coordinating and managing all aspects of external quality system audits, including FDA, ISO 13485, notified bodies and other external agencies.
• Supports R&D initiatives by providing Design Assurance support through all phases of the product development process, with specific focus on risk management.
• Supports clinical initiatives by assisting with preparation of documents for competent authority and ethics committee reviews.
• Leads the internal audit program through scheduling, executing, and reporting of internal audit activities/ results to Leadership Team.
• Implements and maintains the CAPA system to meet 21CFR820, ISO 13485, 93/42/EEC and internal VytronUS requirements. This includes leading CAPA Board meetings, maintaining and presenting metrics to the Leadership team, etc.
• Implements and maintains Supplier Management process in accordance with 21CRF820, ISO 13485, 93/42/EEC and internal VytronUS requirements. This includes creation and maintenance of Quality Agreements, supplier assessments and audit (as needed), maintenance of the ASL and supplier reassessments when required.
• As Management Representative, responsible for preparing and conducting quality performance measurements including developing, tracking, and publishing metrics, ensuring company awareness of regulatory and customer requirements and preparing for and presenting to the leadership team on the performance of the quality system.
• Work collaboratively with Regulatory group in support of company objectives towards device approval in US and international markets
• Work collaboratively with Operations Group to maintain cleanroom standards and ensure disposable product manufacturing yields and throughput objectives are achieved.
• Supervise Quality team comprising of 2-3 direct and other indirect reports
• Writes/ revises SOPs, Forms, Templates in accordance with business and regulatory compliance standards
• Other duties as assigned.
Individual must be motivated to work independently as well as with teams. They must be able to manage multiple tasks and prioritize appropriately. Must be detail oriented with good written, verbal and organizational skills. PC proficient (e.g., Windows, Word, Excel, PowerPoint).
• B.S. in Science, Engineering or equivalent combination of education and experience
• Minimum 10+ years' experience in medical device industry with increasing responsibility
• 5+ years' experience managing employees
• Experience in managing the following standards: 21CFR820, ISO 13485, ISO 14971, MDR 2017/745, 93/42/EEC - Medical Device Directive, ISO 10993, ISO 62304, ISO 60601, ISO 62366
• ISO 13485 Lead Auditor Certification and/or ASQ Quality Auditor
• Demonstrated ability to work with international health authorities
• Experience working in a start-up environment
Additional Requirements:• Experience with ManufactPro or other electronic documentation system