ISO 13485 Registered

Employment Opportunities

Quality Engineer I/II           

Stellartech is looking for a Quality Engineer to join our Team.

Responsibilities:

  • 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 0-2 years relevant experience is required. Participation in ASQ is desired.


To inquire about these opportunities, please contact us at jobs@stellartec.com

← BACK

visual