Quality Assurance Manager
4 weeks ago
TestPros is seeking an experienced Quality Assurance Manager to lead our QA efforts in responding to an FDA project. The ideal candidate will have a strong background in regulatory compliance, particularly with FDA regulations, and will ensure that all deliverables meet the highest quality standards.
Key Responsibilities:
- 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.
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:
TestPros offers 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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