At Abbott, we're committed to helping people live their best possible life through the power of health. For more than125years, we've brought new products andtechnologies to the world -- in nutrition, diagnostics,medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than150 countries we serve.
Ensure that computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory, divisional and corporate requirements. Provide direction and leadership for instrument and data management software validation: planning, scheduling, protocol creation, test execution, and review. Develop and apply advanced theories, methods / process, and research techniques to make risk evaluations, sound technical decisions, and process improvements to assure the safety and efficacy of software used in products produced by ADC. This shall be accomplished in accordance with applicable domestic and international regulations and standards. Interface with related software development engineering or consultants, IT, as well as other project manager and software users/developers site wide.
Support and develop strategies for new development and upgrades to instrument and data management software systems releases in the US and Worldwide by leading and coordinating the software validation activities. Provide leadership, direction and expertise to teams in development of test related documentation, including test plans, test scripts/protocols, and defect reports. Ensure robustness and effectiveness of software testing methodologies and processes. Manage department resources to ensure timely SWQA deliverables per project milestones. Support Engineering Change Control reviews and approvals, ensuring compliance to applicable quality and regulatory requirements. Develop, implement and maintain Division process and department operating procedures to ensure compliance to FDA QSR, ISO 13485, 21 CFR Part 11 and Abbott Corporate and Divisional requirements as they relate to the development, validation and maintenance of computerized systems used in the Quality System as well as the validation of software used in, or in conjunction with, medical devices. Maintain external contact with other validation groups and consultants to evaluate best practices in organizational design, product development, and technological trends. Actively support personal and professional development of direct reports. Mentor, coach and develop SWQA team. Support internal and external quality system audits.
MINIMUM EDUCATION REQUIRED:
MSpreferred, holds BS/BA in relevant academic discipline and 12years equivalent experience in software testing.
MINIMUM TRAINING & EXPERIENCE REQUIRED:
Knowledge of regulations and standards affecting IVDs and/or Medical Devices. 10 years experience with a firm knowledge of standards such as QSR/ISO/MDD/IVDD, Quality System Requirements, especially as they relate to Software Validation. In particular, has knowledge of Design Control requirements. Has project experience in software testing practices, methodologies and techniques, particularly in testing medical devices. Must have excellent written and oral communication skills. Prior experience in the medical device and/or in-vitro diagnostic industry required. Prior supervisory and management experience also required.
ADC Diabetes Care
United States > Alameda : 1360-1380 South Loop Road
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an8hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.