Accomplished Senior Quality Engineer with more than 15 years of experience in developing and validating medical devices in secure facilities. Possessing exceptional organizational, communication, and technical critical thinking skills, I am recognized as a seasoned and dedicated team player. Known for efficiently managing multiple tasks, I consistently elevate levels of competence and integrity.
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CMM programming, GD&T, PPAP's, SPC, and work instructions.
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Experienced with software testing methodologies, ensuring delivery of high-quality applications. Utilizes test automation and manual testing techniques to identify and resolve defects efficiently. Track record of fostering teamwork and maintaining high standards in dynamic environments.
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Experienced Regulatory Compliance and Quality Management professional Skills ___________________________________________________ Product Safety approvals EMI /EMC qualification Product Test and Reliability Quality Management Systems Supplier Quality Work History ______________________________________________ 11/2017 to 12/2024 Regulatory Compliance and Quality Engineer Xiant Technologies Inc. – Greeley, CO Successfully obtained product safety, RF emissions, and a BLE wireless radio approval of XTi’s LED lighting and information technology products Responsible for system firmware qualification testing prior to field release Mentored engineering staff and management team in Product Safety, Rf emission/ immunity requirements and compliant design solutions Sourced and purchased manufacturing process and engineering test equipment Developed product assembly and test procedures, including raw material inspection instructions Identified and qualified material suppliers, contract manufacturers Supported and participated in large scale on-site installations across the US 07/2010 to 08/2017 Directory of Quality Terralux Inc. – Longmont, CO Obtained and managed over 100 LED lighting product safety approvals using standards; UL 8750, UL 1598, UL 1993, UL 1598C, CSA C22.2 No.250. Implemented and managed all quality functions within the organization. Responsibilities included IQC/OQC inspections, production training, CAPA, MRB, failure analysis, RDT, and warranty processing. ISO 9001 Management Representative, with authority for implementing and maintaining Terralux’s Quality Management System. Scheduled and hosted ISO and customer quality audits. Engineering Change board member with approval authority for product and process changes, including temporary deviations. Specified and submitted capital expense requests to purchase tools and equipment used for product inspection, test verification, and reliability qualification. 7/2008 to 7/2010 Quality Manager Pure Energy Solutions – Boulder CO Successfully qualified several products with a large OEM, securing a $14 million sales and distribution agreement Responsible for supporting all issues related to product quality and customer satisfaction. Production assembly and quality process support for domestic and Asian manufacturing facilities. 5/2004 to 3/2008 Staff Engineer, Regulatory Compliance, Tandberg Data – Boulder CO. Efficient project management skills, providing on-schedule regulatory certifications, effective factory support, and detailed file maintenance for the entire product line Sole responsibility for all regulatory approvals Effective interpretation and application of product safety, electromagnetic emissions and immunity standards. Including but not limited to IEC/EN 60950-1, EN 55022, EN 55024, and EU CE Marking and RoHs Directives Solution driven assistance to design team to ensure compliant product designs and mitigation of non-compliant product issues Implemented European and Chinese RoHS verification measures throughout supply chain 5/2003 to 5/2004 Product Safety Engineer / Front-line Manager, Nemko USA – Boulder CO. Developed and managed new product safety certification business in Colorado. Operated and maintained a fully functional product safety test lab. Certified CB Report reviewer to IEC/EN Standard 60950-1 Evaluated and tested various product types (ITE, Medical, T&ME) for compliance to Domestic and European product safety standards, including IEC 60601, 60950-1, and IEC/EN 61010-1. Issued compliant EN and CB test reports and worked with clients to correct non-conformances. 1/1990 to 3/2003 Staff Engineer, Product Compliance Exabyte Corporation – Boulder CO. Established on-site electrical product safety test lab, which was approved under UL’s client test data program. Installed semi-anechoic chamber and shield room facilities for pre-compliance EMC testing. Performed in-house shock, vibration, and packaging testing Eight years as the lead Product Safety Engineer for product compliance team. Equipped with strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.
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Adept Software Quality Assurance Engineer with a proven track record at Purpose Financial, where I excelled in developing QA test cases and enhancing software reliability through meticulous functional and regression testing. My collaborative skills, alongside expertise in test documentation and defect tracking, significantly uplifted project quality standards.
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Detail-oriented Quality Engineer skilled in implementing robust quality assurance processes and ensuring compliance with ISO standards. Manages cross-functional collaboration to support successful new product developments and product transfers. Drives continuous improvement initiatives that enhance product quality and operational efficiency.
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Dynamic Quality Assurance Engineer with proven success at ATOS / Eviden, enhancing product reliability through meticulous regression testing and effective collaboration with development teams. Experienced with software testing and quality assurance methodologies, ensuring high product standards. Utilizes test plans and defect tracking to identify and resolve issues efficiently. Knowledge of industry best practices and commitment to continuous improvement. I excel in Agile environments, ensuring high-quality software delivery while fostering strong communication across teams.
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I am a highly motivated professional dedicated to lifelong learning and eager to embrace new challenges. With a strong work ethic, adaptability, and exceptional interpersonal skills, I excel at working independently and rapidly acquiring new skills. My 20-year career spans the Semiconductor, Biotech, Aerospace, and Defense industries.
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