Quality Assurance Specialist

Nabsys is advancing genomics with a clear focus on accessibility and innovation through its proprietary electronic genome mapping (EGM) technology. Implemented on the OhmX Platform™, EGM integrates precision electronics, nanofluidics, and computational biology to deliver high-resolution insight into genome structure. This approach expands what’s possible in cytogenetics, molecular genetics, and cell and gene therapy research, while providing comprehensive structural variation analysis to laboratories of all sizes.

The company was founded in 2005 and is based in Providence, Rhode Island. For more information, visit

Title:
Quality Assurance Specialist

Nature of Role: Reporting to the Quality Manager, the Quality Assurance Specialist ensures product and process quality in a regulated environment, with a focus on documentation, audits, data analysis, root cause analysis, and Corrective and Preventive Actions.

Responsibilities:

• Represents quality and regulatory compliance organization
• Supports product development and compliance activities
• Ensures quality and compliance requirements are met at each stage from concept to launch
• Impacts projects, processes, and procedures with an in-depth knowledge of Nabsys processes and ISO standards
• Creates a Continuous Improvement culture by monitoring quality metrics and driving process improvement activities
• Writes and submits reports as required for audits, design reviews, and CAPAs, liaising as needed with SME (Subject Matter Experts) to solve product issues
• Complete special projects and other duties as assigned

Requirements:

• Bachelor’s degree, preferably in Molecular Biology or Engineering
• 4+ years professional experience with at least 2 years in medical devices or regulated industry
• Excellent written and verbal communication - able to speak, listen, and write in both technical and non-technical terms across organizations and at all levels
• Experience with statistical analysis
• Familiarity with standards (ISO, ASTM, ASME)
• Demonstrated analytical, problem solving, root cause analysis as well as experience leading and implementing change
• Proficient with ISO 9001, ISO 13485, FDA, EU MDR, and software lifecycle standards (ISO 62304)
• Experience with supplier quality, CAPA, nonconforming materials, and process improvement
• Knowledge of Software as a Medical Device (SaMD) or Software within a device
• Knowledge of Design Controls, Risk Management, and Verification & Validation

Compensation:

• Competitive salary and bonus structure
• Equity stake
• Benefits include health, dental, vision, 401(k) plan with 50% match up to 6% of base salary, unlimited vacation, life insurance