Quality Management System Specialist

Quality Management System Specialist

Portage - MI

In this role, you 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.

Work Flexibility

Hybrid – must reside within a commutable distance to Portage, MI and work onsite several times per week.

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

Required

• Bachelor’s degree in science, engineering, business, or a related discipline.
• 0+ years of experience working in a regulated industry environment.

Preferred

• Knowledge of U.S. and international medical device regulatory requirements.
• Experience supporting quality systems such as audits, management review, quality planning, and corrective action processes.
• Experience supporting regulated information systems or quality systems change control.
• Exposure to good manufacturing and distribution practices within a quality environment.