Software Quality Assurance Engineer
- Support the development, implementation, and maintenance of software quality assurance processes in accordance with FDA and ISO standards.
- Review and approve documentation related to software development, validation, and risk management.
- Collaborate with cross-functional teams including R&D, Regulatory, and Manufacturing to ensure software compliance throughout the product lifecycle.
- Participate in audits and inspections, providing subject matter expertise on software quality and compliance.
- Ensure adherence to 21 CFR Part 11, ISO 13485, and other applicable regulations and standards.
- Contribute to continuous improvement initiatives within the quality system.
- Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
- Minimum of 4 years of experience in software quality assurance or computer systems validation, preferably in the medical device or life sciences industry.
- Strong knowledge of the Software Development Life Cycle (SDLC) and risk-based validation approaches.
- Familiarity with regulatory requirements including 21 CFR Part 11, ISO 13485, and FDA guidance documents.
- Excellent communication, documentation, and organizational skills.
FAQs
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