Quality Engineer II
Stellartech is looking for a Quality Engineer to join our Team.
- 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.
- 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.
- 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.
- Assist in process validation activities for new and current products.
- Assist in maintenance and improvement of the Quality System with guidance of QA Management, including internal audits, external audits, and quality improvement activities.
- 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.
- Participate in Hazard Assessment, Failure Mode and Effect Analysis, and risk management analysis, as required, for new and current products.
- Assist in the preparation of regulatory submissions to the U. S. FDA and other regulatory agencies.
- Review and approve Device History Records for products finished device release as required.
- Serve as a technical resource for technicians, assemblers, and other Stellartech personnel.
- Perform other duties as Supervisor may direct.
Skills & Qualifications:
Typically requires a BS degree or equivalent. At least 1-3 years relevant experience is required. Participation in ASQ is desired.
To inquire about these opportunities, please contact us at email@example.com