IT Lead Quality Analyst
About The Position
The IT Lead Quality Analyst at Applied Medical leads a team of quality analysts and ensures applications and software meet quality system requirements and compliance standards within a regulated environment. This position manages software validation projects, contributes to the direction of the software validation program, and is responsible for ensuring that validation processes and standard operating procedures are followed consistently across the team. The IT Lead Quality Analyst brings proven leadership experience, advanced knowledge of the Software Development Lifecycle (SDLC), and a track record of delivering compliant, audit-ready validation programs. Professionals with backgrounds in software quality assurance leadership, software validation management, or regulated environment quality programs will find this role well-aligned with their experience.
Requirements
- Bachelor's degree in Computer Science, Information Systems, or equivalent
- Minimum of five years of experience testing and validating software in a regulated environment
- Demonstrated leadership skills, including experience leading a team of quality analysts
- Experience managing software validation for projects and change requests in a regulated environment
- Experience collaborating with software developers, business analysts, and project managers
- Experience writing and approving test plans and test cases
- Ability to analyze complex user and software requirements for testability
- Demonstrated project management skills with the ability to handle multiple projects and tasks within a cross-functional team
- Proficiency with quality metrics, status reporting, and test management tools
- Proficiency with Microsoft Azure DevOps
- Proficiency with Microsoft Office
- Advanced knowledge of the Software Development Lifecycle
- Advanced analytical and problem-solving skills
- Advanced technical writing skills
- Ability to mentor, coach, and develop team members
- Strong written and verbal communication skills
- Demonstrated organizational skills
Nice To Haves
- Experience with SAP system validation or SAP-related quality processes
Responsibilities
- Lead a team of quality analysts and manage software validation activities across multiple projects and change requests.
- Create, review, and approve software validation documents, including software change requests, validation summary reports, validation plans, software risk assessments, and requirements traceability matrices.
- Review and approve test results and audit test runs to ensure accuracy, completeness, and regulatory compliance.
- Contribute to project plans by preparing deliverables and timelines for software validation activities, ensuring projects are completed on schedule.
- Support internal and external audits related to software validation processes and standard operating procedures.
- Research and evaluate new information systems and technologies, recommending solutions that drive innovation and efficiency.
- Take a leadership role in the training and career development of team members, coaching analysts to develop skills and achieve professional goals.
- Assist with quality metrics trending and analysis to monitor program performance and identify areas for improvement.
- Collaborate closely with members of the ATS Corporate Applications team and cross-functional partners across Applied Medical.
Benefits
- Competitive compensation range: $75000 - $115000 / year (California).
- Comprehensive benefits package.
- Training and mentorship opportunities.
- On-campus wellness activities.
- Education reimbursement program.
- 401(k) program with discretionary employer match.
- Generous vacation accrual and paid holiday schedule.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
