Now Hiring - JenaValve Technology Inc. - Senior Manager, Corporate Documentation Change Management System in Irvine, CA

Full description of the position

Job Title : Senior Manager, Corporate Documentation Change Management System Supervisor/Manager Title: Global Director, Quality Job Description Summary: This individual is responsible for building and leading the Corporate Documentation Change Management System, ensuring successful adoption and integration of changes within the organization. This role requires a strategic and innovative mindset to guide the organization through significant company growth and transformation, while enhancing performance and achieving business objectives. This individual is expected to envision and spearhead the overhaul of the current document control system to a state-of-the-art Corporate Documentation Change Management System that supports the growing business needs with a focus on efficiency, compliance and usability. Job Responsibilities: * Design a scalable, structured, and compliant approach in improving the current change management to meet the needs of all stakeholders. * Develop actionable change management strategies for large-scale internal change initiatives with clear goals and expected outcomes * Develop, maintain and present departmental KPIs as part of continuous improvement initiatives * Support internal and external audit activities as needed * Provide management with status updates on assigned responsibilities and goals and escalate issues appropriately. * Ensure compliance to change control procedures. * Coach, mentor, and develop team members across sites * Establish or modify procedures, as necessary, to maintain compliance regulations and efficiencies for stakeholders * Manage operations of the Corporate Documentation Change Management System to ensure efficient and effective support to users of the system. This includes: * Assuring that the cross-site group is staffed appropriately. * Providing direction. support and development opportunities to group members. * Setting priorities and objectives for group members. * Measuring the performance of the group and individuals in the group. * Support, as necessary, external audits of the JenaValve QMS. * Interface with users of the system to better anticipate requirements and manage expectations. Required Education and Experience: * Minimum B.S. in engineering; American Society of Quality Certified Quality Engineer (ASQ CQE) or master's degree a plus. * At least ten (10) years' work experience in the medical device industry or regulated industry. * At least ten (10) years' work experience in quality engineering or quality assurance. * Must be able to apply quality principles (GMPs, 21 CFR 820, ISO 13485) to Change Control practices. * Ability to lead multi-disciplinary teams, anticipate potential risks and establish mitigation to achieve long term project success. * Travel up to 10% of the time Skills and Abilities Required for This Job: * Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers. * Excellent computer proficiency (MS Office - Word, Excel, Visio, Outlook) and experience with use of ERP and eQMS systems. * Strong influencing and negotiation skills. * Great attention to detail