Job Description
RIVANNA is seeking a meticulous and detail-oriented Quality Assurance Specialist to join our team. The ideal candidate will have a strong engineering background, with a bachelor’s degree in engineering, along with practical experience in Quality Assurance within the medical device industry.
Responsibilities:
- Perform quality inspections and audits on medical devices, ensuring compliance with regulatory standards and internal quality protocols.
- Collaborate with cross-functional teams including engineering, manufacturing, and regulatory affairs to identify and resolve quality issues.
- Develop and implement quality control procedures and protocols to maintain product integrity throughout the manufacturing process.
- Conduct root cause analysis and corrective action investigations for non-conformances or quality incidents.
- Participate in the review and approval of manufacturing and design documentation, including SOPs, work instructions, and engineering drawings.
- Assist in the validation and qualification of equipment and processes to ensure they meet regulatory requirements and industry standards.
- Support continuous improvement initiatives to enhance product quality, reliability, and efficiency.
Education and Requirements:
- Bachelor’s degree in engineering or related field.
- Previous experience in Quality Assurance within the medical device industry, preferably in a QA technician or operations role.
- Familiarity with medical device regulations and standards, such as ISO 13485.
- Strong analytical skills and attention to detail.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Proficiency in Microsoft Office suite and quality management software.
- Ability to work independently and prioritize tasks in a fast-paced environment.
RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, 401(k) with match, and more. We are always looking to complement our existing team with individuals who bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.
RIVANNA Medical 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 accommodation may be made to enable individuals with disabilities to perform essential functions.
About Rivanna Medical, Inc.
RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA 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 ?rst spinal navigation device designed to improve safety, speed, and efficiency of spinal needle guidance procedures. RIVANNA'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.
Requirements: