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 Paart 820, and IVDR.
- Assists with training related to Quality Assurance Inspection - QAI.
Job Posting Qualifications
- Bachelor's degree required.
- Experience ISO 13485, 21 CFR Paart 820, and IVDR. required
- 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.