Quality Associate (Medical Device) (Cedar Creek)

Job Title : Quality Associate

Location : Cedar Creek, Texas 78612

Duration : 12-18 months

Job Description :

Primary Responsibilities :

Support intermediate and final kit level inspection and final product release for high-profile product lines.

Identifies opportunities for improvement in Quality processes for Cedar Creek reagent products and consumables and implements corrective and preventive actions accordingly

Performs final physical inspections of the product.

Completes documentation for all inspections.

Uses SAP to perform all computer-related tasks.

Supports final product release of Cedar Creek products via physical inspection and document review.

Ensures compliance with relevant regulations and guidelines, ISO 13485, 21 CFR Part 820, and IVDR.

Assists with training related to Quality Assurance Inspection - QAI.

Qualifications :

Bachelors degree required in life science

1+ years relevant quality experience in a manufacturing environment.

1+ years of SAP experience.

Focused on product release processes, ensuring accuracy and timeliness.

Must be analytical, detail-oriented, and possess strong time management skills.

Ability to multitask, stay organized, and prioritize effectively in a fast-paced environment.