US-FL-FtLauderdale: Quality Systems Engineer
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Quality Systems Engineer
* Participates as a cross-functional team member in new product development or sustaining project team activities, representing the interests and concerns of the quality assurance/quality engineering function.
* Leads quality improvement projects that benefit the inspection, testing, assembly, or development of products.
* Keeps abreast of changes to domestic and international regulations, standards, and guidance documents.
* Identifies and drives continuous quality improvement in area of responsibility.
* Understands and is able to review quality records to verify information is correct and complete and that specifications have been met.
* Conducts failure investigation to analyze internal system or process failures and implement preventive and corrective action. Uses various statistical and non-statistical problem-solving tools as part of analysis.
* Assists in the training of Quality Assurance, Development, and/or Production employees in Quality System related procedures or improvement programs.
* Implements and maintains systems to report and improve quality. Maintains a complete awareness of the cost of quality and promote activities to monitor and reduce quality costs.
* B.S. degree in an engineering discipline required. ME or IE preferred. A minimum of five years experience in quality assurance / quality systems plus a minimum of 3 years recent experience in the medical device industry required, NPD area preferred.
* Must be able to identify and recommend effective solutions to problems, utilizing technical problem solving tools, and working individually and with others within and outside his/her function.
* Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
* Must show self-initiative but be comfortable in the role of a team player. Must be able to manage multiple projects and report progress against goals in an objective manner.
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Team SQAFYI - Software QA Resource FYI