Senior Design Quality Engineer

1 week ago

Jackson, United States CYNET SYSTEMS Full time

Job Description: Responsibilities: Ensure software validation of regulated non-product software systems is executed according to established SOPs and produces compliant deliverables. Collaborate with cross-functional teams to model development and production processes in an item-based management system. Complete and support end-to-end verification and validation of integrated systems used in medical device production, distribution, and monitoring. Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Identify and implement process improvement methodologies where applicable. Ensure compliance with applicable regulatory requirements, procedures, and standards. Maintain project schedules, report progress, and present results to cross-functional teams. Support development and maintenance of design history files, design control activities, and risk management documentation. Requirement/Must Have: 3+ years of experience in medical device quality/regulatory roles. Familiarity with 21 CFR Part 11, 21 CFR 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, and other applicable regulations. Experience interpreting regulatory requirements and following standard operating procedures. Experience with design control and risk management activities for medical devices. Strong organizational, management, and interpersonal skills. Excellent verbal and written communication skills. Qualification and Education: B.S. degree in Mechanical, Electrical, Biomedical, Computer Science, or equivalent engineering/science discipline. Preferred Skills: Experience working on software used to produce or monitor medical devices (MES, configuration management systems, post-market surveillance systems, design and development systems). Cross-functional collaboration and experience interacting with engineering design teams.

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