Quality Systems Specialist

Brief Description

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
  

Requirements

• Bachelor’s degree in Quality Management, Engineering, or related field preferred (relevant experience may be considered in lieu of degree)
• Minimum of 3 years of experience in Quality Management, preferably within the medical device industry
• Ability to travel up to 15% (domestic)
• Strong attention to detail with the ability to perform tasks accurately and consistently
• Excellent written, verbal, and interpersonal communication skills, with proficiency in MS Office applications
• Familiarity with electronic Quality Management Systems (eQMS) (e.g., Grand Avenue)
• Ability to manage multiple projects and adapt to shifting priorities
• Strong critical thinking and analytical skills with a proactive, problem-solving mindset
• Working knowledge of Root Cause Analysis, Risk Analysis, and Auditing techniques (training may be provided)
• Ability to work independently, take initiative, and operate effectively with minimal direction
  
  

Physical Requirements & Work Environment

• Ability to occasionally lift up to 50 pounds
• Primarily sedentary work, including extended periods of sitting and computer use
  
  

Summary

We offer a competitive annual salary paid bi-weekly within the $55,000 to $67,000 range, based on experience and qualifications, along with annual bonus and profit-sharing opportunities tied to performance.

Beyond pay, our market-leading benefits are designed to support your wellbeing. These include medical, dental, vision, and life insurance, as well as short- and long-term disability coverage. We also provide a health savings account with company match, a retirement plan with employer contributions through Vanguard, and access to the Granite Assistance Fund for support when it’s needed most. We value time for rest and personal growth, offering generous paid time off, including volunteer time off and paid holidays.