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Quality Engineering Associate

2 months ago

Milpitas, California, United States Stellartech Research Corporation Full time
Job Overview

PRIMARY RESPONSIBILITIES:

  1. Engage in quality engineering initiatives for innovative product designs by collaborating with Engineering to formulate design and development strategies, as well as compiling necessary documentation.
  2. Examine and authorize Device Master Record documentation for new product development and ongoing maintenance, which includes bills of materials, assembly instructions, manufacturing processes, assembly schematics, testing protocols, component specifications, labeling, and user manuals.
  3. Conduct continuous quality engineering assessments on existing products to enhance product designs and/or manufacturing methodologies, including involvement in Non-Conformance Management, Complaint handling, and Corrective and Preventive Actions as required.
  4. Support process validation efforts for both new and existing products.
  5. Contribute to the upkeep and enhancement of the Quality Management System under the guidance of Quality Assurance Management, which encompasses internal and external audits, as well as quality improvement initiatives.
  6. Assist Engineering in the formulation and execution of verification and validation protocols, along with the corresponding test reports for new products and modifications to existing products.
  7. Participate in Hazard Assessments, Failure Mode and Effects Analysis, and risk management evaluations as necessary for both new and existing products.
  8. Aid in the preparation of regulatory submissions to the U.S. Food and Drug Administration and other relevant regulatory bodies.
  9. Review and validate Device History Records for product release as required.
  10. Act as a technical resource for technicians, assemblers, and other personnel within Stellartech Research Corporation.
  11. Perform additional tasks as directed by the Supervisor.

QUALIFICATIONS:

Typically requires a Bachelor's degree or equivalent experience. This is an entry-level position; prior experience is not mandatory but is preferred. Involvement in the American Society for Quality is encouraged.