Quality Engineer

Salary Range:$110,000.00 To $125,000.00 Annually

Compensation will be determined based on the candidate’s level of experience and qualification

sBe part of a mission that matters—join Theragenics as a Quality Engineer and help ensure the safety, quality, and performance of life-saving medical devices used in cutting-edge cancer treatments and minimally invasive procedures

.Company Overview At Theragenics, we’re passionate about transforming healthcare and enhancing patient outcomes. With innovation at our core, we develop medical devices for cancer treatment, vascular procedures, and surgical applications. We proudly operate Arrotek, a visionary design consultancy in the U.S. and Ireland, dedicated to pioneering minimally invasive solutions

.Role Summary As a Quality Engineer, you’ll plan, execute, document, and maintain validation and verification activities to ensure compliance with FDA, ISO 13485, and EU MDR standards. You’ll collaborate with cross-functional teams to support both design services and contract manufacturing in a fast-paced environment

.Key Responsibilitie

• sDevelop and release Design Verification & Validation plans, protocols, and reports
• .Ensure compliance with Design Control requirements and maintain traceability across user needs, inputs, outputs, and testing
• .Develop and validate inspection/test methods and support equipment qualification
• .Create validation master plans, perform statistical analysis, and support revalidation/change management
• .Maintain DHF and DMR documentation, support CAPA investigations, and conduct root cause analysis

.Qualifications & Skill

• sBachelor’s degree in Engineering or related field
• .Experience in medical device validation, verification, or quality assurance
• .Knowledge of FDA regulations, ISO 13485, and GMP
• .Strong analytical, documentation, and communication skills
• .Ability to work independently and collaboratively in a regulated environment

.Why Join U

• sCareer growth opportunities in a mission-driven company
• .Exposure to innovative projects shaping the future of patient care
• .Collaborative culture with global impact
• .Competitive benefits and compensation
• .Purpose-driven work that directly improves lives

.Ready to make a difference? Apply today and be part of something extraordinary

."We don’t just ship inventory; we deliver care." "Healthcare that is both high-tech and human, with a global reach but a personal impact.