Senior Quality Assurance Engineer for Software
2 weeks ago
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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