Associate QE

ESSENTIAL FUNCTION:

1. Perform quality engineering development activities for new product designs by assisting Engineering in the preparation of design and development plans, Design History File documentation, and Design History File preparation.
2. Review and approve Device Master Record documentation for new product design and maintenance, including bills of material, assembly procedures, manufacturing operations, assembly diagrams, test procedures, component specifications, labeling, and operator’s manuals.
3. Perform ongoing quality engineering activities on current products to improve product designs and/or manufacturing processes including participation in NCM, Complaint, and CAPA investigations and actions as necessary.
4. Assist in process validation activities for new and current products.
5. Assist in maintenance and improvement of the Quality System with guidance of QA Management, including internal audits, external audits, and quality improvement activities.
6. Assist Engineering in the preparation and execution of verification and validation protocols and verification and validation test reports for new products and changes to current products.
7. Participate in Hazard Assessment, Failure Mode and Effect Analysis, and risk management analysis, as required, for new and current products.
8. Assist in the preparation of regulatory submissions to the U. S. FDA and other regulatory agencies.
9. Review and approve Device History Records for products finished device release as required.

1. Serve as a technical resource for technicians, assemblers, and other Stellartech personnel.
2. Perform other duties as Supervisor may direct.

EDUCATION AND EXPERIENCE:

Typically requires a Bachelor’s degree or equivalent. Entrance level position, previous experience is not required, but is desired. Participation in ASQ is desired.