Company Overview

TestPros is a successful and growing business, established in 1988 to provide Information Technology (IT) technical support services to a wide range of Commercial and U.S. Federal, State, and Local Government customers. Our capabilities include Program Management, Program Oversight, Process Audit, Intelligence Analysis, Cyber Security, NIST SP 800-171 Assessment and Compliance, Computer Forensics, Software Assurance, Software Testing, Test Automation, Section 508 and WCAG Accessibility Assessment, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and Development (R&D) services. TestPros is an Equal Opportunity Employer.

TestPros delivers innovative independent IT assessment solutions to critical challenges facing the nation and the world.  We support the U.S. Federal Government and Commercial clients within the continental USA. TestPros is dedicated to making lives better, safer and more secure.

Job Title: Quality Assurance (QA)

Citizenship: U.S. Citizenship

Location: Hybrid ( Rockville, MD and/or Silver Spring, MD and/or telework/remotely as directed by the COR)

Clearance: Public Trust Clearance 

Job Summary: We are seeking an experienced Quality Assurance (QA) 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. This role involves managing QA processes, leading a team of QA professionals, and ensuring all products and services comply with FDA requirements.

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.

  Preferred Skills:

• Advanced degree in Quality Assurance, Regulatory Affairs, or a related field.

• Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma).

• Experience with electronic quality management systems (eQMS).

• Familiarity with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).

  Key Competencies:

• Attention to Detail: Ensure thoroughness and accuracy in testing and documentation.

• Regulatory Knowledge: In-depth understanding of FDA regulations and compliance requirements.

• Leadership: Ability to guide and motivate the QA team to achieve high standards.

• Communication: Effectively convey information and ideas to various stakeholders.

• Risk Management: Identify and mitigate quality and compliance risks effectively.

  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!  All benefits are per TestPros current policies and are subject to change without notice.  Benefits are available to full-time employees only.

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