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Software Validation Engineer
Provides validation expertise for special process and software validations through planning, protocol development, execution support, and report development. Examples of special processes requiring validation are compression molding, cleaning and passivation processes; examples of software validations are CNC equipment, PLC controllers, customized and off-the-shelf software. This position is also responsible for the review and update of validated processes and software at predefined frequencies.
Develops statistical rationale for validation activities in accordance with internal and external policies and procedures.
Supports the Supplier Quality department with the assessment and approval of vendor supplied special process validations.
Performs internal quality systems audits in order to ensure compliance with federal and international regulatory and quality system requirements.
Responsible for defining, implementing and follow-up of systematic corrective and preventive actions (CAPA) as assigned.
Provides regulatory support for third party audits (FDA, Notified Body) throughout the corporation as needed
Performs related duties as required.
Knowledge: A Bachelorís Degree from an accredited college or university is required. Five to eight years of experience working in the medical device or a related industry is preferred. Knowledge of FDA and regulations and how to interpret and monitor them, as well as experience in Quality Systems relating to 21 QSR Parts 11 / 820 and ISO 13485:2003 is preferred. Knowledge of CAPA, Quality Planning, Process Validation and Quality Auditing is also preferred. Computer skills required, including Microsoft Excel.
Skills: Proficiency in Microsoft Office software is necessary.
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