In this role, the selected candidate must be an individual with extensive knowledge of medical device quality system regulations (i.e. FDAs Quality System Regulation and ISO 13485) and the ability to develop, implement and maintain a quality system compliant with these requirements.
In this role, you will work with developers, system administrators, nationally recognized security analysts, and product management to ensure that we deliver high quality products that meet or exceed industry test standards.
In this role, the selected candidate will provide assistance in performing disciplined problem solving for supplier, customer, and internal quality defect; maintains knowledge of all products, processes, and basic quality principles required to assist with daily operations and continual improvement activities.
In this role, you will be developing professional expertise, applies company policies and procedures to represent the Quality Systems Department on software development teams as a software validation partner.
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$60K to $80K -Portsmouth, RI
In this role, the selected candidate will write reports to pull data from various sources, filter information, identify trends, make conclusions. Drive corrective and preventative action, continual Improvement.
The Quality Engineer will provide and analyze statistical information for quality improvement by identifying testing methods and samples. Plans and directs activities concerned with development, application, and maintenance of quality standards for industrial processes, material, and products:
This position is responsible for participating in the execution of procedures for ensuring the quality and serviceability of new features and releases of software. Authors and executes test cases and testing methodology for manual and/or automated tests.
In this role the CQE will provide detailed product inspection as mandated by corporate procedures and checklists to validate/verify product authenticity, condition and offer documented, factual information for Sales and/or Commodity Management to determine disposition when applicable.
In this role, you will manage individual customer self-release programs including procedure preparation and maintenance, purchase order/control review, inspection of parts (audit/sampling) for conformance to requirements, direct contact with customer representatives and handling any customer returns/complaints.