Quality Assurance Lead : Healthcare & Pharma background only.

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Job Overview

The Quality Assurance Lead at TekNavigators Staffing will play a pivotal role in ensuring the delivery of high-quality products and services in the healthcare and pharmaceutical domains. The successful candidate will be responsible for developing and implementing robust QA methodologies, conducting risk assessments, providing insights on process improvements, and leading a team of QA professionals. This role requires collaboration with cross-functional teams to ensure compliance with industry regulations and standards while consistently striving for operational excellence.

Job Responsibilities

• Develop and implement comprehensive quality assurance strategies tailored for healthcare and pharmaceutical products.
• Lead the QA team in executing testing plans, including automated and manual testing approaches.
• Conduct risk assessments to identify areas for improvement in QA processes.
• Create and maintain QA documentation such as test cases, test plans, and defect reports.
• Collaborate with product development and IT teams to ensure quality standards are met throughout the product lifecycle.
• Monitor compliance with industry regulations and standards including FDA, ISO, and GxP guidelines.
• Provide training and mentorship to QA staff on best practices and methodologies.
• Analyze QA metrics to identify trends and make data-driven recommendations for improvement.
• Act as a primary point of contact for quality-related inquiries and issues within the organization.

Qualifications

• Bachelor’s degree in a relevant field; advanced degrees or certifications preferred (e.g., Six Sigma, ASQ certification).
• 5+ years of experience in quality assurance, specifically in the healthcare or pharmaceutical industries.
• Demonstrated experience leading QA teams and managing complex projects.
• Strong knowledge of QA methodologies, tools, and processes applicable to the healthcare sector.
• Excellent analytical skills with the ability to interpret data and metrics effectively.
• Exceptional communication and interpersonal skills to collaborate with diverse teams.
• Proficient in software testing tools and practices, including automated testing frameworks.
• Familiarity with industry regulations such as FDA, ISO, and GxP is essential.

Technologies & Tools

The Quality Assurance Lead will utilize a variety of technologies and tools crucial for ensuring product quality and compliance. This includes automated testing frameworks such as Selenium and QTP, performance testing tools like LoadRunner, and defect tracking software such as JIRA. Additionally, familiarity with CI/CD pipelines, version control systems like Git, and collaborative project management tools will be essential for driving efficiency within the QA process.

Ideal Candidates

Ideal candidates for the Quality Assurance Lead position are detail-oriented individuals with a strong passion for quality and compliance in healthcare and pharmaceuticals. They possess exceptional leadership skills, foster a team-oriented environment, and exhibit a proactive approach to problem-solving. A commitment to maintaining high standards of quality, along with the ability to adapt in a fast-paced environment, will distinguish them as valuable members of the TekNavigators Staffing team.