Quality Assurance Specialist

Topcon Healthcare Solutions (THS), headquartered in Oakland, NJ, is a leading software engineering company of the eye care industry. THS is responsible for R&D, engineering, marketing, sales, and support of software solutions to the global market.
Topcon's mission is to make the impossible possible, by constantly innovating optical, imaging, and measurement technologies and developing new and advanced image management and networking solutions. Our goal is simple: to provide the ophthalmic medical community with the most innovative and indispensable software solutions so that doctors and researchers can better serve patients, ultimately improving outcomes in eye and vision care. THS is newly established in 2017 to provide the most advanced software solutions to the global market. We focus on IoT, Cloud and AI technologies to enable "Healthcare through the eye".
The QA Specialist will support Complaint and CAPA handling as well as nonconformance investigations, to ensure company compliance according to Quality System Requirements and Quality Management System.
Responsible for analyzing and investigating of our software product complaints (related to medical device software) or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.
Develops or updates company complaint and inspection procedures to ensure issues are captured and investigations occurs, as well as proper documentation of complaints.
Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development.
Work closely with internal departments for resolution of CAPA and Supplier Corrective Action Requests.
May perform audits and risk assessments.
Assist in other Quality Assurance tasks as required.
Education & Experience:
BS or MS in Computer Science/Computer Engineering or related fields.
2-3 years experience in a quality role within a software company or direct interaction with software solution complaints
Knowledge, Skills, and Abilities:
Familiarity with FDA QSR Requirements
Ability to troubleshoot, diagnose and document technical complaints
ServiceMax and 123Compliance
Experience with Customer support for Software/ Hardware preferred
Ability to work independently and efficiently; good organizational and investigational skills; ability to follow detailed written procedures; able to handle multiple tasks simultaneously and prioritize accordingly;
Good communication skills, verbal and written; good analytical ability; ability to work well with others; good problem-solving skills; detail-oriented.

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