||Quality Engineer II - Equipment
The incumbent applies software and/or systems engineering and quality assurance principles and techniques to the software and product development lifecycles. The position will also perform software and/or system testing for NxStage medical devices and other
business software and/or systems that supports the Quality System.
• Assist in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations.
• Develop and implement instructions/methods for inspecting, testing and evaluating product conformance to specification.
• Assist with and perform audits for evaluation of supplier compliance with the Quality System Regulations.
• Conduct internal audits for evaluation of compliance with the Quality System Regulations.
• Process non-conforming material reports including MRB dispositioning.
• Assist in supporting manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
• Assist in maintaining quality system information databases as assigned. Evaluate quality data and prepare periodic reports to monitor trends.
• Complete activities associated with the formal release of product to finished goods
• Support Engineering in the development, testing, verification, validation and commercialization of new products.
• Work with internal groups in creating project documents, and performing verification and validation testing required in an FDA-regulated environment.
• Assist project teams in assessing the required validation activities for software systems.
• Develop and execute procedures and scripts meant to test the performance of the following software:
– Software contained in NxStage commercially distributed products.
– Software used in the manufacture and/or testing of NxStage products.
– Software used in NxStage quality systems.
• Lead team reviews related to software validation
• Perform device system and performance testing in the lab.
• Develop testing strategies and software risk analyses.
||Education & Qualifications:
• B.S. in Computer Science or Engineering Related Field
• 3+ years related quality assurance, software quality engineering experience or an equivalent combination of experience and education. Medical device experience preferred.
• ASQ certification a plus.
• Beginning knowledge of FDA Quality System Regulation 21 CFR Part 820.
• Good organizational, attention to detail and follow-through skills
• Excellent verbal communication and customer interface skills.
• Ability to interface with multiple groups in the organization.
• Systems - Basic computer skills – word processing, spreadsheet, windows. MS Office preferred.
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