Quality Engineer I

Rivanna Medical, Inc. • Charlottesville, VA

1h • Onsite

About The Position

RIVANNA is seeking a Quality Engineer I to help ensure manufacturing processes consistently meet performance and quality specifications. This role will play a key part in driving operational excellence through process monitoring, equipment validation, and continuous improvement initiatives.

Requirements

• Bachelor’s degree; applicable experience may be considered in lieu of degree
• Biomedical-related degree and medical device experience
• Competency with Microsoft Excel and document control systems
• Experience with FDA 21 CFR 820, ISO 13485 (Quality Management), ISO 14971 (Risk Management), CE Marking, Class II medical devices that use software
• Experience with Arena PLM
• 1-3 years work experience

Responsibilities

• Training and compliance with all Company standard operating procedures (SOP’s) within its ISO 13485 certified quality management system
• Interface with the research and development team to transfer new designs to manufacturing
• Execute incoming inspection and basic in-process inspection protocols
• Support nonconformance report generation and basic investigation
• Support CAPA investigations with structured problem solving
• Optimize manufacturing operations to reduce scrap, improve efficiency, and routinely meet quality and operations team objectives
• Execute manufacturing tasks, including but not limited to, product validation, troubleshooting, and non-conformance evaluations
• Design, develop, and implement new manufacturing processes and test systems to optimize product quality and production efficiency
• Manage and improve product servicing and repair activities
• Assist with audits from the FDA and other regulatory bodies

Benefits

• health insurance
• vision and dental coverage
• group life insurance
• long-term disability insurance
• paid time off
• a 401(k) plan with company match

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level