$50K - 70K a year
Manage QMS documentation and compliance, support audits and CAPA activities, and handle customer service operations including order processing and customer inquiries.
Bachelor's degree in a technical/scientific field, proficiency in Microsoft Office and Visio, experience with QMS and CRM, understanding of medical device compliance, and customer service or sales experience.
Company Join a high-growth company in the Medical Device industry. They are seeking a high-performing Document Control Specialist to join their dynamic team. Position Overview The Document Control Specialist is a dual-role where you’ll make a direct impact on both product quality and customer experience. You’ll help shape and grow their Quality Management System (QMS), ensuring they meet the highest industry standards, and even take the lead during unannounced audits—keeping their reputation for excellence intact. You’ll work hands-on with SOPs, CAPAs, customer feedback, and supplier files, gaining valuable exposure to regulatory processes. In your capacity as a Customer Service Representative, you’ll be at the heart of operations—partnering with leadership to issue quotes, fulfill domestic and international orders, coordinate with the warehouse, and deliver outstanding service to customers worldwide. This is a unique opportunity to build skills across quality, compliance, and operations in a fast-moving, mission-driven medical device company. Position Details • Status: Full-Time • Hybrid: Onsite 1-2 Days Per Week • Location: Chicago, IL Quality Responsibilities • Support the upkeep and improvement of the Quality Management System (QMS) to ensure all processes, documentation, and records meet current regulatory and industry standards. • Manage controlled documents, supplier evaluations, and training records, ensuring they are accurate, current, and in compliance with company procedures and global regulatory requirements. • Assist with audits, CAPA activities, and product complaint investigations, as well as regulatory compliance for new product development from planning through launch. • Coordinate internal audits and step in to host external audits when leadership is unavailable. Customer Service Responsibilities • Act as a first point of contact for customers, handling inquiries, orders, returns, and account updates in a professional and timely manner. • Prepare quotes, process domestic and international orders, and work with warehouse and leadership teams to ensure accurate, on-time delivery. • Manage order and inventory data in company systems, including e-commerce and accounting platforms, while supporting international shipping documentation. • Assist leadership with high-priority operational tasks, including urgent customer needs and potential product recall coordination. Qualifications • Bachelor's Degree in a technical or scientific discipline • Proficiency in Microsoft Office and Visio • Experience with QMS (Quality Management System), CRM (Customer Relationship Management), and regulatory documentation • Understanding of standards and compliance requirements for medical devices • Sales and/or customer service experience • Interpersonal and communication skills • Strategic mindset with attention to detail Compensation & Benefits • Base Salary according to experience • Benefits Package • Retirement plan If you're an experienced Quality Associate or Document Control Specialist, we invite you to apply and be part of shaping the future of the Medical Device industry. By applying, you give your consent to be submitted to our client for this opportunity. Only qualified candidates will be contacted.
This job posting was last updated on 9/16/2025