Sr Quality Management System Specialist in Portage

Work Flexibility: Hybrid The Senior Quality Management System Specialist will help design, maintain, and continuously improve a quality management system that supports regulatory approval and business growth across global markets. You’ll collaborate across functions to ensure quality processes are not only compliant, but practical, efficient, and future‑ready. Activities include Quality System documentation, Internal Quality Agreements, Supplier Quality Agreements, and general QMS activities related to Mergers and Acquisitions. This role is Hybrid in Portage, Michigan . What You Will Do Support and maintain a compliant Quality Management System aligned with global medical device regulations to enable product certification and regulatory clearances. Develop and update quality system processes, procedures, and documentation to reflect business needs and regulatory expectations. Assess and quantify quality system requirements to optimize structure, integration, and scalability. Identify and implement continuous improvement opportunities that increase efficiency and effectiveness of quality processes. Support management review, quality planning forums, and related governance activities with data-driven inputs. Partner with stakeholders to ensure quality processes reflect actual operational activities, including support for new product development. Prepare for and support internal, external, and third‑party quality system audits, including responses and follow‑up actions. Contribute to quality system training content and delivery to ensure effective adoption across the organization. What You Will Need Bachelor’s degree in science, engineering, business, or a related discipline. <