About this role
Contribute to maintaining and improving quality systems to ensure compliance with global regulatory requirements and assuring that the quality systems are used effectively to support company quality policy and objectives. Support the preliminary investigation on CAPA/QAR/audit findings, prepare and analyze reports/metrics, update procedures, and participate in facilitate Quality Systems related discussions. Drive activities related to Quality System improvements. Job duties: Maintain CAPA process. Partner with CAPA owners to investigate issues related to audit findings, CAPA, and QAR by collaborating with various functions (e.g., R&D, Production, Field Assurance, etc.). Facilitate CAPA Review Board meetings, prepare data to be analyzed for CAPAs, and follow up on actions to drive on-time delivery of committed actions. Lead and support CAPA owners in understanding and conveying problem statements, conducting thorough root cause investigations and analyses, proposing logical and achievable corrective/preventive actions, and following up to ensure actions are effective and completed on time. Maintain CAPA records to ensure that they are presentable. Support auditing activities and provide leadership for internal audits conducted by Terumo Neuro associates or consultants. Support preparation and hosting activities for third-party audits including FDA, Notified Body, and corporate and international regulatory authorities. Support follow-up efforts. Prepare and improve quality system metrics and regularly analyze trends to drive improvement on overall Quality System programs. Partner with associates in other functions to evaluate and analyze the efforts in organizing, documenting, and making recommendations to management on quality improvement processes. Develop and conduct quality-related training, including CAPA process, conducting root cause investigations, and quality improvement processes. Lead the planning and implementation of quality improvement initiatives. Identify and escalate critical issues that warrant further actions. Create and/or revise procedures to ensure compliance or drive improvement. Cross-trained as internal auditor to support Internal Audit process. Lead projects and may supervise Technicians, Assemblers, and others as needed. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. Perform additional duties as assigned.