Quality Engineer I at Rivanna Medical, Inc.

Charlottesville, Virginia, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

0.0

Posted On

13 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

ISO 13485, FDA 21 CFR 820, ISO 14971, CAPA Investigations, Process Validation, Incoming Inspection, Arena PLM, Microsoft Excel, Nonconformance Reporting, Risk Management, CE Marking, Document Control

Industry

Medical Equipment Manufacturing

Description

Description 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. Job 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 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 About Rivanna Medical, Inc.: Rivanna Medical, Inc. is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. Rivanna Medical, Inc. operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world's first spinal navigation device designed to improve the safety, speed, and efficiency of spinal needle guidance procedures. Rivanna Medical, Inc.'s revolutionary platforms feature BoneEnhance® Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation. Employee Benefits at Rivanna Medical, Inc.: Rivanna Medical, Inc. offers a comprehensive benefits package, which includes health insurance, vision and dental coverage, group life insurance, long-term disability insurance, paid time off, a 401(k) plan with company match, and more. We are continually seeking to enhance our team with individuals who bring unique perspectives and experiences. This diversity of thought and perspective drives innovation and strengthens our commitment to creating an inclusive team environment where our core values of trust, humility, and dedication are practiced every day. Equal Employment Opportunity Statement: Rivanna Medical, Inc. is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws. All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of their positions.

Responsibilities

Ensure manufacturing processes meet quality specifications through process monitoring, equipment validation, and continuous improvement. Responsibilities include managing nonconformance reports, supporting CAPA investigations, and interfacing with R&D for design transfers.