QA Specialist - DHR

the Client•Irving, TX

4d•Onsite

About The Position

This role supports the final release of finished medical device products, with a primary focus on reviewing Device History Records (DHR) for accuracy, completeness, and compliance. The company is a global healthcare innovator that has been advancing medical technology for more than 140 years, delivering life-changing solutions across medical devices, diagnostics, nutritional science, and pharmaceutical products to patients in more than 160 countries. The organization's portfolio spans cardiovascular care, diabetes management, diagnostic testing, nutrition, and neuromodulation, with recognized brands that millions of people rely on every day. Operating across four major business segments — medical devices, nutritional products, diagnostics, and established pharmaceuticals — this organization employs biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals who collaborate across cross-functional, international teams. Certified as a Great Place to Work, with 80 percent of employees reporting it as a great place to work — well above the national average — this company offers real resources for development, meaningful mission alignment, and a culture grounded in inclusion and innovation.

Requirements

Strong attention to detail
Effective communication
Problem-solving ability
Teamwork and collaboration
Ability to work independently with minimal supervision
0–2 years of quality, manufacturing, or documentation review experience.
Ability to work with minimal guidance and follow defined procedures.

Nice To Haves

Quality Assurance background is a plus
Quality Assurance (QA) experience
Batch Release experience
Non-conformance documentation
Process improvement involvement

Responsibilities

Support final release of finished medical device products.
Review Device History Records (DHR) for accuracy, completeness, and compliance.
Verify that released products meet established quality standards before shipment.
Review both 3rd floor Instrument products and ACP jobs.
Identify documentation errors and escalate quality issues as needed.
Collaborate with cross-functional teams to resolve issues and support continuous improvement.