Lead, Computer Systems Validation - New York

Employment Type

: Full-Time


: Electronics/Semiconductors

Responsibilities Provide proactive quality support regarding best practices, document management, process development/improvement and risk management for computer systems. Enhance and implement Flatirons quality system to ensure compliance with applicable regulatory requirements. Assess internal compliance with Flatirons quality system. Determine the appropriate level of qualification and validation necessary for electronic systems and engineering tools to ensure compliance with relevant regulations and industry guidance documents. Design, implement and oversee risk-based computer systems validation activities (e.g. specifications, testing, qualification, release). Guide and reconcile any associated corrective and preventive actions needed to ensure compliance.

Individuals seeking employment at Flatiron Health are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Provide hands-on project management and support to ensure the completion of computer system validation and the associated documentation (e.g. plans, protocols, reports, memos).

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Foster a quality culture focused on meeting high quality, ethical and compliance standards. voluntary Enhance and implement document management and training plans for a compliant approach to the software development lifecycle (SDLC). Design, implement and oversee compliance training. Ensure proactive audits/inspection readiness. Oversee external audits/inspections of Flatirons data and research businesses, including liaising with clients, hosting on-site visits, and internal oversight of associated action plans. Plan, complete, document and closure audits of Flatiron vendors. Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

Collaborate with our Product Management, Quantitative Science, Abstraction, Oncology, Security and Software Engineering teams to advise on the correct application of internal and external requirements for computer systems projects.

A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A \"recently separated veteran\" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.


An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

Applicants with at least 4 years of experience with completion of day to day validation activities.

An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Experience of working within a highly regulated environment (e.g. licensed laboratory, commercial manufacturing, life sciences)
Associated topics: asic, cadence, chip, design, engineer i, engineer ii, engineer iv, hardware engineer, rf, vlsi

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