Quality Specialist

Role overview

Burton Medical is hiring an on-site Quality Specialist for its Addison, Illinois office in the Greater Chicago Area. This is an exempt position reporting to the Head of Quality and Regulatory, and sponsorship is not available for this opening.

What you'll do

• Move quality documents into an electronic QMS and carry out testing and validation activities for the system.
• Handle eQMS administration tasks such as document control, training records, and system administration.
• Oversee the DCR/ECO workflow, including documentation updates and retention of QMS records.
• Spot training needs for both new and existing employees, build training plans, and keep training logs current.
• Conduct internal audits and support responses to notified body audits.
• Investigate product and process failures, determine root causes, track trends, and contribute to CAPA work.
• Inspect components and finished goods and review non-conformances.
• Be available on-site to complete the first review and final release of routers for production work.
• Support production when non-conformances arise on the manufacturing line.
• Lead MRB meetings for NCR cases and coordinate with Purchasing on vendor concerns and SCARs.
• Review scrap data and work with management on product disposition decisions.
• Manage the calibration program by monitoring equipment and coordinating vendor quotes and shipments through Purchasing.
• Maintain test, maintenance, and environmental monitoring records for the plant.
• Use working knowledge of FDA 21 CFR Part 820 to help maintain ISO 13485 certification and improve the QMS through process upgrades.
• Support regulatory work such as registrations, adverse event reporting, UDI implementation, and changes tied to regulatory updates.
• Compile, analyze, and present data for projects and management reviews.
• Take on additional assignments from the Head of Quality and Regulatory Affairs as needed.

What we're looking for

• High school diploma, associate degree, or equivalent; a B.S. in science or engineering is an advantage.
• At least 4 years of relevant experience, ideally in manufacturing or an ISO 13485-certified environment.
• Strong spoken and written English; Spanish is considered a plus.
• Solid documentation discipline, accuracy, and ability to manage tasks and filing carefully.
• Comfortable using Word, Excel, Outlook, and ideally ERP systems and Adobe tools.
• Hands-on experience with an electronic QMS is required, such as MasterControl or Greenlight Guru.
• Working knowledge of ISO 13485 and FDA requirements.
• Proven ability to collaborate across functions.
• Capability to lead and support continuous improvement efforts.
• Ability to read drawings and use measuring tools for inspection and calibration work.
• Willing to work evenings and weekends when business needs require it.
• Experience with Class I and II medical devices is preferred.
• Prior exposure to ISO/FDA audits is preferred.

Additional information

This role is based on-site in Addison, Illinois. No sponsorship is available at this time.

Work authorization and schedule

The company is looking for someone who can work evenings and weekends when necessary.