• Support and lead QMS activities related to Document Control, QMS management, CAPA, Risk Management and Complaints • Lead and Implement improvements to drive compliance, quality, and efficiency of these processes • Investigate nonconformities and use appropriate tools to determine the root cause • Develop product knowledge to make informed decisions that influence product quality and safety • Support audits by promptly delivering complete and accurate records • Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes • Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed • Support efforts to ensure the organization operates within established policies/procedures and complies with all applicable governmental regulations, both domestic and foreign • Assist during audits in the room (supplier, critical supplier, notified body, or otherwise) • Stay current with the latest guidance documents, regulatory requirements, and industry best practices