Nabsys · 6 hours ago
Quality Assurance Specialist
Providence, RI
Full-time
Hybrid
Mid Level
4+ years expNabsys is advancing genomics with a clear focus on accessibility and innovation through its proprietary electronic genome mapping technology. The Quality Assurance Specialist ensures product and process quality in a regulated environment, focusing on documentation, audits, data analysis, and corrective actions.
BiotechnologyGeneticsHealth CareMedical
Hiring Manager
Stephanie Chamberlin, SPHR, HCS
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
Qualification
Required
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
Preferred
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
Benefits
Health
Dental
Vision
401(k) plan with 50% match up to 6% of base salary
Unlimited vacation
Life insurance
Company
Nabsys
Nabsys is a life sciences company focused on the development of solid-state, single-molecule positional sequencing technology.
11-50 employees
H1B Sponsorship
Nabsys has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (4)
Funding
Current Stage
Late StageTotal Funding
$143.3MKey Investors
Hitachi High-TechnologiesStata Venture Partners (SVP)PJC
2024-08-01Acquired
2022-11-09Corporate Round· $13M
2022-04-13Corporate Round· $25M
Leadership Team
Barrett Bready
Founder & CEO
M
Michael Kaiser
SVP, Software and Informatics
Recent News
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