Quality Assurance Manager

8 hours ago

Silver Spring, Maryland, United States TestPros Full time
Job Title: Quality Assurance Manager

At TestPros, we are seeking an experienced Quality Assurance Manager to lead our QA efforts in responding to an FDA project. As a key member of our team, you will be responsible for ensuring that all deliverables meet the highest quality standards.

Key Responsibilities:
  • Oversee the development and implementation of QA processes to ensure compliance with FDA regulations and guidelines.
  • Lead and manage a team of QA professionals, 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.
Qualifications:
  • 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.
Benefits and Perks:
  • 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.

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