Providence, RI
Quality Assurance Specialist
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.
- 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
- 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
Desired:
- 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
