Quality Engineer

3 weeks ago

Montgomery, United States GForce Life Sciences Full time

Responsibilities: Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations, and Product Performance Analysis teams to ensure compliance with LifeScan software development procedures and industry regulations. Review and approve deliverables throughout the software development lifecycle. Lead teams in conducting Hazard Analysis to identify and mitigate potential risks. Occasionally assist teams in developing Standard Operating Procedures (SOPs) and Work Instructions tailored to software development activities. Occasionally provide training for specific software development activities within LifeScan. Write and execute test protocols and reports as needed.

Requirements: Bachelor's degree in Computer Science, Software Engineering, or related field. 0-3 years of experience in software development or compliance within a regulated industry. Knowledge of software development procedures and industry regulations. Strong communication and collaboration skills to work effectively with cross-functional teams. Ability to analyze complex technical information and ensure compliance with standards and regulations. Attention to detail and ability to review and approve software deliverables. Experience with Hazard Analysis and developing SOPs and Work Instructions is a plus.

Term & Start: Site located in Westbrook, ME 6:00 AM - 2:30 PM

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