IT QA Manager

Job not on LinkedIn

August 29

Apply Now

Receive Emails with Similar Jobs

Integer Holdings Corporation

WebsiteLinkedInAll Job Openings

Healthcare Insurance • Pharmaceuticals • Biotechnology

Integer Holdings Corporation is a leading provider of advanced medical device outsourcing services. With a rich history of 80 years, Integer specializes in the design, development, and manufacturing of medical devices and components. It serves major global OEMs by offering a wide range of products such as finished device systems, Class III Medical Devices, and components for cardiac rhythm management, neuromodulation, and vascular health markets. Integer is renowned for its manufacturing excellence, innovation, and commitment to enhancing patient lives through high-quality medical solutions. The company operates globally, providing unique design expertise, comprehensive product development, and strategic partnerships in the medical device industry.

10,000+ employees

Founded 1970

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

💰 Post-IPO Debt on 2023-01

📋 Description

• Lead a team of QA resources (manual, automation and performance testers) providing technical guidance. • Lead the planning, development, and execution of test strategies and plans for IT systems supporting manufacturing operations. • Ensure compliance with 21 CFR Part 820, GxP, and CSV requirements throughout the software development lifecycle. • Develop and maintain IQ, OQ, PQ protocols and ensure proper execution and documentation. • Collaborate with internal project stakeholder Identify testing needs and scope. • Define and execute test strategies, plans and schedules for complex applications across multiple platforms. • Design, develop test automation frameworks using tools - Estimate testing resources and timelines. • Secure and coordinate testing resources and activities. • Drive performance testing initiatives using tools like LoadRunner, NeoLoad. • Review and approve validation documentation, including test scripts, traceability matrices, and summary reports. • Participate in audits and inspections, providing evidence of compliance and validation activities. • Continuously improve ITQA processes, tools, and methodologies to enhance efficiency and effectiveness. • Provide training and mentorship to team members and project stakeholders on validation and testing best practices. • Provide regular status updates, QA metrics, and test coverage reports to stakeholders. • Knowledge & Skills Required: • Bachelor’s degree in Computer Science, Information Systems, Engineering, or a related field. • 7+ years of experience in IT Quality Assurance, with at least 3 years in a lead role. • Deep understanding of software development life cycles, agile/scrum methodologies • Strong knowledge of FDA regulations, particularly 21 CFR Part 820 and GAMP 5. • Hands-on experience with IQ/OQ/PQ testing and Computer System Validation (CSV). • Experience working in a regulated manufacturing or life sciences environment. • Proven ability to manage external testing teams and coordinate with cross-functional stakeholders. • Excellent communication, documentation, and organizational skills. • Knowledge & Skills Required: Experience with automated, performance testing tools and test management platforms. • Familiarity with ERP, MES or other manufacturing-related systems. • Certification in Quality Assurance or Validation (e.g., ASQ, ISPE, ISTQB or similar). • Work Environment: Hybrid or on-site work model depending on project needs. May require occasional travel to manufacturing sites and/or vendor locations.

🎯 Requirements

• Lead a team of QA resources (manual, automation and performance testers) providing technical guidance. • Lead the planning, development, and execution of test strategies and plans for IT systems supporting manufacturing operations. • Ensure compliance with 21 CFR Part 820, GxP, and CSV requirements throughout the software development lifecycle. • Develop and maintain IQ, OQ, PQ protocols and ensure proper execution and documentation. • Collaborate with internal project stakeholder Identify testing needs and scope. • Define and execute test strategies, plans and schedules for complex applications across multiple platforms. • Design, develop test automation frameworks using tools - Estimate testing resources and timelines. • Secure and coordinate testing resources and activities. • Drive performance testing initiatives using tools like LoadRunner, NeoLoad. • Review and approve validation documentation, including test scripts, traceability matrices, and summary reports. • Participate in audits and inspections, providing evidence of compliance and validation activities. • Continuously improve ITQA processes, tools, and methodologies to enhance efficiency and effectiveness. • Provide training and mentorship to team members and project stakeholders on validation and testing best practices. • Provide regular status updates, QA metrics, and test coverage reports to stakeholders. • Knowledge & Skills Required: • Bachelor’s degree in Computer Science, Information Systems, Engineering, or a related field. • 7+ years of experience in IT Quality Assurance, with at least 3 years in a lead role. • Deep understanding of software development life cycles, agile/scrum methodologies • Strong knowledge of FDA regulations, particularly 21 CFR Part 820 and GAMP 5. • Hands-on experience with IQ/OQ/PQ testing and Computer System Validation (CSV). • Experience working in a regulated manufacturing or life sciences environment. • Proven ability to manage external testing teams and coordinate with cross-functional stakeholders. • Excellent communication, documentation, and organizational skills. • Knowledge & Skills Required: Experience with automated, performance testing tools and test management platforms. • Familiarity with ERP, MES or other manufacturing-related systems. • Certification in Quality Assurance or Validation (e.g., ASQ, ISPE, ISTQB or similar). • Work Environment: Hybrid or on-site work model depending on project needs. May require occasional travel to manufacturing sites and/or vendor locations.

🏖️ Benefits

• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits • Parental leave after one year • Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance • Employees are immediately eligible to participate in the 401(k) plan with company matching contributions • 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off