Senior Quality Assurance Engineer for Software

2 weeks ago


Irving, Texas, United States Intellectt Inc Full time

Position: Senior Software Quality Engineer

Company: Intellectt Inc

Role Overview:

The Senior Software Quality Engineer plays a crucial role in ensuring the highest quality standards in software development. This position involves a comprehensive understanding of design control processes and risk management principles.

Key Responsibilities:

  • Design and Change Management: Engage in the development and evaluation of design inputs, risk assessments, and validation protocols to ensure compliance with industry standards.
  • Risk Assessment: Apply fundamental risk management techniques and contribute to the creation and revision of Risk Management Files and Failure Mode Effects Analysis (FMEA).
  • Verification and Validation: Utilize established methods for design verification and validation, participating in the creation and review of relevant documentation.
  • Issue Resolution: Analyze complex complaints and defects, providing effective solutions while ensuring thorough documentation.
  • Documentation Review: Scrutinize project documentation for precision, clarity, and adherence to compliance standards across varying complexities.
  • Quality Compliance: Stay informed about regulatory standards and ensure adherence to company policies, promptly addressing any compliance issues.
  • Collaboration: Work alongside project teams and technical review boards to facilitate quality decisions and ensure the delivery of safe and effective products.

Essential Skills and Qualifications:

  • Minimum of 5 years of experience in the medical device software development lifecycle, with a preference for In Vitro Diagnostics (IVD).
  • Familiarity with ISO standards related to Medical Device Quality Management Systems and Risk Management.
  • Experience with FDA design controls.
  • Proven background in software verification and validation.

Educational Background:

A Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, Life Sciences, or a closely related field is required. A Master’s degree is preferred. Candidates should have at least 4 years of experience covering the entire software lifecycle and design control processes in a collaborative environment.

Interview Process:

Preference will be given to onsite interviews, although initial phone screenings may be conducted.



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