Systems Integration Engineer - Job number 1809
Date posted: August 25, 2008
Location: Research Triangle Park, NC
Job type: Full-time
Industry: Manufacturing
Description:
Under the supervision of the Manager, Systems Integration, this position is responsible for: Supporting the design, system, assay and software verification and validation operations in support of all Projects. (80%) Working with the R&D and RA/QA departments to improve and implement policies and procedures for verification and Validation efforts consistence with the company’s Quality Management System. (20%) Duties Include: •Working with software developers and stake holders to develop software requirement specifications. •Develop and conduct Master Verification and Validation Plan for software validation, systems validation and assay validation. •Compiles Verification and Validation results in preparation for FDA and other agency submissions. •Works with RA/QA in support of the submission process to FDA and other regulatory bodies. •Work with RA/QA and other department in the refinement of the Quality Management System. •Ensure Systems Integration in compliance with the Quality Management System. •Supports the internal and external Audit processes. •Authors SOPs and other documents applicable to Systems Integration operations.
Qualifications: Bachelor's degree required, preferably in Engineering, Science and Computer Science. •Minimum of three years experience in software verification and validation testing at FDA related manufacturing or laboratory operations. •Familiarity with Verification and Validation concepts, procedures, protocols and requirements. •Knowledge of FDA regulations of design control for medical device (IVD). •General knowledge of quality systems implemented in medical device or in vitro diagnostic companies applicable to ISO or other formal processes. •Documentation standards applicable for ensuring compliance with FDA QSR and generally accepted industry practices. •Generally accepted industry standards for software and device verification and validation methodology. •The ability to learn and understand medical systems, assays and software to a level appropriate for verification and validation efforts. •The ability to clearly and concisely write and verbally communicate requirements, technical data and concepts and experimental results. •The ability to establish effective relationships with other departments in establishing initial expectations for verification and validation efforts. •The ability to read, understand and conform policies and procedures. •The ability to comprehend and execute verbal or written direction from a supervisor. •Excellent organizational, record retention and time management skills. •Excellent decision making and creative problem solving skills. •Ability to develop, organize, and manage multiple tasks.
For confidential consideration, please email your resume and salary requirements to: claire@fullscalesolutions.com
Category: Pharmaceutical/Biotech
Company: Full Scale Solutions
Full Scale Solutions, Inc. is a Human Capital management company that provides exceptional recruiting solutions to companies to help them grow.