Software Test & Evaluation • Quality Assurance • Configuration Managment • IV&V • RMF A&A
May 30
🇺🇸 United States – Remote
🦀 Maryland – Remote
⏰ Full Time
🟡 Mid-level
🟠 Senior
🔧 QA Engineer (Quality Assurance)
Software Test & Evaluation • Quality Assurance • Configuration Managment • IV&V • RMF A&A
• Oversee the development and implementation of QA processes • Ensure all project activities comply with FDA regulations and guidelines • Lead and manage the QA team, providing guidance and support to ensure the team meets project goals • Develop and execute test plans, scripts, and procedures to ensure product quality and compliance • Conduct regular audits and reviews to ensure adherence to quality standards and regulatory requirements • Collaborate with cross-functional teams, including Regulatory Affairs, Product Development, and Project Management, to ensure quality requirements are met • Prepare and present QA reports and documentation • Stay current with FDA regulations, guidelines, and best practices to ensure ongoing compliance • Identify potential risks and develop mitigation strategies to address quality and compliance issues
• Bachelor’s degree in Quality Assurance, Regulatory Affairs, Life Sciences, or a related field • Minimum of 5 years of experience in quality assurance, with a focus on FDA-regulated industries • Proven experience managing QA teams • Strong knowledge of FDA regulations, guidelines, and quality standards • Excellent analytical, problem-solving, and decision-making skills • Strong leadership and team management abilities • Exceptional communication and interpersonal skills
• competitive salary • medical/dental/vision insurance • life insurance • 3 weeks of paid vacation • 2 weeks of paid federal holidays • education/training and professional certifications • 401(k) retirement plan with up to 4% company match • opportunities for professional growth and much more!
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