IT Lead Quality Analyst

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

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.

Key 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.

Success in This Role Looks Like

• Leads a team that consistently delivers compliant, audit-ready validation documentation across all assigned projects and change requests.
• Manages project timelines and validation deliverables effectively, ensuring on-time completion across a multi-project environment.
• Builds a team culture of quality, accountability, and continuous development through active coaching and mentoring of individual analysts.
• Maintains strong working relationships with software developers, business analysts, project managers, and cross-functional stakeholders.
• Supports audit readiness by ensuring validation processes and standard operating procedures are followed consistently across the team.
• Identifies opportunities to improve the software validation program and implements solutions that enhance efficiency and quality outcomes.
• Contributes to the strategic direction of the software validation program at Applied Medical through informed recommendations and consistent leadership presence.

Position Requirements

This position requires the following skills and attributes:

• 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

Preferred

The following skills and attributes are preferred:

• Experience with SAP system validation or SAP-related quality processes

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.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.