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 Lead Quality Analyst will lead a team and ensure applications and software meet quality system requirements and compliance standards for software validation within a regulated environment. The Lead Quality Analyst will manage software validation projects and contribute to the direction of the software validation program at Applied Medical. The Lead Quality Analyst is also responsible for ensuring that software validation procedures are followed.

• Lead a team and manage software validation activities on various projects and change requests.

• Review and approve test cases using Applied Medical's test management tool.

• Approve software validation documents, such as software change requests, software validation summary reports, software validation plans, software risk assessments and traceability matrices.

• Review and approve test results and audit test runs.

• Contribute to project plans by preparing deliverables and timelines for software validation activities.

• Ensure projects are completed in a timely manner.

• Research and evaluate new information systems and technologies and recommend solutions that drive innovation.

• Take a leadership role in the training and development of team members.

• Review and approve training content and facilitate select training workshops, as needed.

• Assist with trending and analysis as needed.

• Continued learning about information systems.

• Perform other duties and responsibilities as needed.

• Work closely with various team members within the Corporate Applications team.

• May work with other team members within Applied Medical, as needed.

Position Requirements

This position requires the following skills and attributes:

• Bachelor's degree in computer science, Information Systems, or equivalent.

• A minimum of five years' experience testing and validating software.

• Demonstrated leadership skills.

• Demonstrated organizational skills.

• Experience leading a team of Quality Analysts.

• Experience leading the 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.

• Proficient in quality metrics and status reporting.

• Ability to concurrently handle multiple tasks while working within a cross-functional team.

• Advanced analytical and problem-solving skills.

• Demonstrated project management skills.

• Ability to mentor and train other team members.

• Experience coaching team members to develop skills and achieve goals.

• Effective written and verbal communication skills.

• Ability to work well in a team environment.

• Advanced technical writing skills.

• Advanced knowledge of the software development life cycle.

• Proficient with Microsoft Office and Visio

• Proficient with test management tools.

• Experience with Microsoft Azure DevOps.

• Preferred experience with SAP.

Preferred

The following skills and attributes are preferred:

• Experience with SAP.

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.