Software Quality Engineer

Flex, a leading manufacturing partner for market-leading brands, is seeking a Software Quality Engineer for their Austin, TX location. This role is crucial in ensuring software quality for medical device manufacturing processes. The position reports to the Quality Manager and focuses on software validation, verification, and compliance with internal policies and regulatory requirements.

The ideal candidate will have 6 years of experience in high-technology electronics engineering, with specific expertise in software validation within the medical device, pharmaceutical, or biotechnology industry. Knowledge of CFR Part 820, Part 11, ISO 13485, and Annex 11 is essential. The role involves managing software validation activities, ensuring compliance, and interfacing with customers on technical quality issues.

Key responsibilities include overseeing software validation/verification activities, implementing validation policies for IT systems, managing regulatory audits, and coordinating product assurance programs. The position requires strong technical expertise combined with project management skills and understanding of software development life cycle (SDLC) and GAMP standards.

Flex offers a comprehensive benefits package including medical, dental, and vision plans, life insurance, disability coverage, 401(k) matching, paid time off, and tuition reimbursement. The company promotes an inclusive work environment and values diversity in its workforce. This role presents an excellent opportunity for a qualified professional to join a global leader in manufacturing solutions while working on critical quality assurance processes in the medical device industry.