Quality Engineer

2 months ago


Temecula, United States GForce Life Sciences Full time

This role involves collaborating closely with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations, and Product Performance Analysis teams to review, approve, and support deliverables throughout the software development lifecycle.

Key Responsibilities:

  • Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations, and Product Performance Analysis teams to ensure compliance with software development procedures and industry regulations.
  • Review and approve deliverables throughout the software development lifecycle.
  • Lead Hazard Analysis activities with cross-functional teams.
  • Occasionally assist in developing Standard Operating Procedures (SOPs) and Work Instructions tailored to software development activities.
  • Provide occasional training sessions on specific software development activities.
  • Write and execute test protocols and reports as needed.

Qualifications:

  • Bachelor’s degree in Computer Science, Engineering, or related field.
  • 3-5 years of experience in software development compliance, preferably in a regulated industry such as medical devices or pharmaceuticals.
  • Strong understanding of software development lifecycle methodologies (e.g., Agile, Waterfall).
  • Familiarity with industry regulations and standards (e.g., FDA regulations, ISO 13485, IEC 62304).
  • Excellent communication and collaboration skills, with the ability to work effectively across diverse teams.


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