Quality Systems Specialist

At Altimate Medical, we design and manufacture innovative medical equipment that supports people living with disabilities in the complex rehabilitation space. Our products help individuals stand taller, move better, and live more independently. And we’re growing!

We operate by three commitments: Build Trust. Deliver Results with Passion. Invest for Good. These are not slogans--they guide how we design products, partner with customers, and develop our people.

AltimateMedical Inc. is hiring a Quality Systems Specialist at our Leggero facility in Burnet, Texas!

The Quality Systems Specialist develops, implements and maintains quality management systems (QMS) procedures to ensure compliance with applicable regulations and standards for US Class I and II medical devices and accessories. This role is responsible for managing site audits, analyzing quality data and driving continuous improvement initiatives. 

If you are looking for a rewarding career where you can make a real difference in people's lives, this could be the opportunity for you. 

What you'll do:

• Serve as the site’s Management Representative for the Quality Management System (QMS), ensuring processes are established, documented, and maintained in compliance with applicable regulations
• Report on QMS performance to top management and drive continuous improvement initiatives
• Promote awareness of regulatory and quality requirements across the organization
• Coordinate and lead Management Reviews to evaluate the effectiveness and suitability of the QMS
• Plan, support, and conduct internal and external audits, ensuring audit readiness and timely follow-up on findings
• Develop and analyze quality metrics to monitor process and product performance and identify improvement opportunities
• Manage customer feedback and complaint handling, including investigation, documentation, and regulatory reporting within required timelines
• Lead Corrective and Preventive Actions (CAPA), including problem definition, root cause analysis, containment, and implementation of solutions
• Collaborate cross-functionally to support investigations, resolve quality issues, and enhance system effectiveness
• Provide support and guidance for key quality system processes, including:
  • Final Inspection
  • Nonconforming Product
  • Returned Material Authorizations (RMA)
  • Receiving Inspection
  • Purchasing Controls
  • Design Controls
  • Risk Management
• Maintain and update risk management files as needed to ensure ongoing compliance
• Support a culture of quality, compliance, and continuous improvement across the site
• Perform additional duties as assigned
• Follow all safety procedures and maintain a clean, safe work environment