VP Quality & Released Product

Job Summary : Responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes, released product engineering processes and documentation in compliance with domestic and international regulatory / quality requirements.   Management Representative for the company.   Essential Functions (Including Regulatory Requirements) : Maintain Quality Management System to support compliance for facility certifications and registrations   in accordance with applicable standards and regulations. Establish and lead the newly created released product engineering (RPE) function Schedule, participate, and assist in follow-up activities for internal audits, supplier audits, and quality / regulatory inspections. Review and revise Quality System documentation to ensure compliance with domestic and international quality  and regulatory requirements specific to new and revised regulations and maintain the   effectiveness of the QMS. Maintain program to ensure adequate training of personnel on quality system  documentation. Work with the HR Department on companywide training activities. Ensure employees are trained in the Quality Systems Regulation and key international regulations and standards. Schedule, prepare documentation, and complete timely quality reviews and management review meetings. Work with contract manufacturers to ensure that devices are manufactured in compliance with US and international quality system requirements. Work with a cross-functional team to evaluate released device field performance, supplier’s ongoing change requests, and overall maintenance of released devices in the marketplace. Implement RPE programs and projects to maintain, improve, and support released devices in the market. Create and maintain a strong working relationship with the PD team for the execution of projects and programs. Assist in the management of the 3rd Party Logistics Supplier – HealthLink Participate in product development team meetings with RPE inputs and oversite for quality and regulatory. Identify and resolve quality / regulatory issues throughout the product development process to ensure successful audits and regulatory submissions. Lead the complaint handling process, support determination of reportability of complaints to US and international regulatory agencies as required. Maintain a functional CAPA system in compliance with applicable regulations. Maintain infrastructure, maintenance, and calibration systems. Oversee internal manufacturing and product evaluations. Support supplier controls purchasing function. Manage, supervise, and train staff, oversee projects ongoing within departments, and carry out departmental administrative duties. Manage the document services function to ensure that quality systems documents, records, and regulatory submissions are controlled. Manage the program for handling product returns, returned product evaluations (and repair / rework, where applicable), complaints, and customer feedback in accordance with internal policies and procedures. Manage product release and non-conforming product activities. Support PMS / PMCF / PSUR activities and requirements. Maintain appropriate trending of data for all relevant QMS functions.   Knowledge / Educational Requirements : Minimum bachelor's level degree. 10-12 years of experience in Quality Assurance and / or Product Development Engineering in the implantable medical device industry. Experience as a functional leader at the Director or VP level. Good working knowledge of domestic and international requirements and regulations such as FDA, ISO, GMP, etc.   Skills and Abilities : Excellent organizational skills and analytical and problem-solving abilities, strong verbal and writing skills, and good interpersonal and leadership skills. Strong PC skills include Windows environment, Word, Excel, and the Internet.       Powered by JazzHR