United States onlyBy living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
General 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 load runner, Neo load.
- 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.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available 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. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
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