Quality Assurance Specialist

Job Title : QA Specialist II Location : Irving, TX 75038 (100% Onsite)

Duration : 6 Months (Possible Extension)

Work Hours : Monday Friday, 8 : 00 AM 5 : 00 PM Job Overview :

We are seeking a QA Specialist II to support quality operations on the production floor for diagnostic instruments and catalog builds in a healthcare manufacturing environment. The ideal candidate will have strong problem-solving skills, experience with GMP and SOP compliance, and the ability to lead cross-functional discussions to resolve product and process issues.

Key Responsibilities :

Represent Quality on the production floor, supporting diagnostic instrument builds.

Lead cross-functional discussions to resolve instrument part nonconformities.

Manage segregation and disposition activities for nonconforming materials.

Maintain and organize quality-critical work areas.

Ensure adherence to GMP and SOP standards.

Conduct root cause analysis , data reviews, and implement corrective actions.

Drive process improvement initiatives to enhance product quality.

Support compliance with internal and external quality requirements.

Required Skills & Experience :

0 3 years of experience in Quality Assurance, Quality Control, or a related field.

Strong understanding of quality tools and methodologies .

Hands-on experience with root cause analysis and troubleshooting .

Ability to interpret data and make informed quality decisions.

Excellent communication and organizational skills.

Preferred : Familiarity with healthcare or diagnostic manufacturing environments.

Education :

Bachelor's degree in Life Science, Engineering , or a related discipline.

Equivalent combination of education and experience will be considered.