IT Lead Quality Analyst

Applied Medical · Rancho Santa Margarita, CA

$75k – $115k/yrPosted Jul 14, 2026

<img src="https://appliedmedical.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=66&hashed=-1305937254" alt="Applied-Medical-Logo-w-Tag_H_Teal_cropped" />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<ul class="[li_&]:mb-0 [li_&]:mt-1 [li_&]:gap-1 [&:not(:last-child)_ul]:pb-1 [&:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3"><li class="font-claude-response-body whitespace-normal break-words pl-2">Lead a team of quality analysts and manage software validation activities across multiple projects and change requests.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Create, review, and approve software validation documents, including software change requests, validation summary reports, validation plans, software risk assessments, and requirements traceability matrices.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Review and approve test results and audit test runs to ensure accuracy, completeness, and regulatory compliance.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Contribute to project plans by preparing deliverables and timelines for software validation activities, ensuring projects are completed on schedule.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Support internal and external audits related to software validation processes and standard operating procedures.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Research and evaluate new information systems and technologies, recommending solutions that drive innovation and efficiency.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Take a leadership role in the training and career development of team members, coaching analysts to develop skills and achieve professional goals.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Assist with quality metrics trending and analysis to monitor program performance and identify areas for improvement.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Collaborate closely with members of the ATS Corporate Applications team and cross-functional partners across Applied Medical.</li></ul>Success in This Role Looks Like<ul class="[li_&]:mb-0 [li_&]:mt-1 [li_&]:gap-1 [&:not(:last-child)_ul]:pb-1 [&:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3"><li class="font-claude-response-body whitespace-normal break-words pl-2">Leads a team that consistently delivers compliant, audit-ready validation documentation across all assigned projects and change requests.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Manages project timelines and validation deliverables effectively, ensuring on-time completion across a multi-project environment.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Builds a team culture of quality, accountability, and continuous development through active coaching and mentoring of individual analysts.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Maintains strong working relationships with software developers, business analysts, project managers, and cross-functional stakeholders.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Supports audit readiness by ensuring validation processes and standard operating procedures are followed consistently across the team.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Identifies opportunities to improve the software validation program and implements solutions that enhance efficiency and quality outcomes.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Contributes to the strategic direction of the software validation program at Applied Medical through informed recommendations and consistent leadership presence.</li></ul> Position Requirements This position requires the following skills and attributes:<ul class="[li_&]:mb-0 [li_&]:mt-1 [li_&]:gap-1 [&:not(:last-child)_ul]:pb-1 [&:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3"><li class="font-claude-response-body whitespace-normal break-words pl-2">Bachelor's degree in Computer Science, Information Systems, or equivalent</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Minimum of five years of experience testing and validating software in a regulated environment</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Demonstrated leadership skills, including experience leading a team of quality analysts</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Experience managing software validation for projects and change requests in a regulated environment</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Experience collaborating with software developers, business analysts, and project managers</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Experience writing and approving test plans and test cases</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Ability to analyze complex user and software requirements for testability</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Demonstrated project management skills with the ability to handle multiple projects and tasks within a cross-functional team</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Proficiency with quality metrics, status reporting, and test management tools</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Proficiency with Microsoft Azure DevOps</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Proficiency with Microsoft Office</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Advanced knowledge of the Software Development Lifecycle</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Advanced analytical and problem-solving skills</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Advanced technical writing skills</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Ability to mentor, coach, and develop team members</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Strong written and verbal communication skills</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Demonstrated organizational skills</li></ul> Preferred The following skills and attributes are preferred:<ul class="[li_&]:mb-0 [li_&]:mt-1 [li_&]:gap-1 [&:not(:last-child)_ul]:pb-1 [&:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3"><li class="font-claude-response-body whitespace-normal break-words pl-2">Experience with SAP system validation or SAP-related quality processes</li></ul> Benefits <ul><li>Competitive compensation range: $75000 - $115000 / year (California). </li><li>Comprehensive benefits package. </li><li>Training and mentorship opportunities. </li><li>On-campus wellness activities. </li><li>Education reimbursement program. </li><li>401(k) program with discretionary employer match. </li><li>Generous vacation accrual and paid holiday schedule. </li></ul>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 EmployerApplied Medical

Originally posted by Applied Medical. View original posting

← Browse all companies

BioCareerAI is an independent job platform and is not affiliated with or endorsed by Applied Medical.