A Software Quality Assurance Engineer III job in Rancho Cordova, CA is available courtesy of Adecco Engineering and Technology. Candidates must be proficient with SAP, management, 21 CFR, ISO 13485, and GAMP 5.
Software Quality Assurance Engineer III Responsibilities:
Your challenge is to provide guidance/approval for the validation of large scale software systems such as SAP used by multiple Business Groups and that deliverables appropriately support local BG Quality Management Systems. This is done through education and partnering with stakeholders across business functions including IT, R&D, Operations and Quality & Regulatory.
Manage, lead and educate business partners across multiple Business Groups (BGs) in the generation, execution and completion of computerized software system and software tool validations.
Provides guidance/feedback to with respect to applicable regulatory requirements and Philips HealthTech policies and procedures.
Authors, reviews and/or approves SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports.
Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process and a actively engage with multiple Business Groups in the establishment/maintenance of software system/tool inventories to provide corporate wide visibility of said inventory.
Successful results from your efforts will directly improve the usability of validation deliverables in each effected Quality Management System (QMS) and drive continuous improvement in the overall management of computerized software systems and validated tools.
Experience & Background:
Minimum 5 - 10 years of experience in validation of large scale computer systems and systems security and control including supervision of a technical professional staff.
Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, and GAMP 5.
Demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives.
Minimum of 7 computerized systems implementations comprised of multiple application types, in a regulated environment.
Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections.
Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
Experience in leading and educating teams on the appropriate documentation created as objective evidence for software validations.
Effective judgment and decision making skills, typically made under stressful situations.
Competency in project management and the execution of multiple projects.
Demonstrated capability in critical thinking and leadership with strong abilities in relationship management.
Ability and willingness to travel 20% domestic and international.
Fluent in English (Bilingual for Costa Rica position)
Education & Training:
Bachelor's degree (BSEE) in engineering and IT related fields; but any advanced degrees are preferable in Quality, Regulatory and Software Engineering.
Minimum of 5 large scale computerized systems implementations comprised of multiple application types, in a regulated environment such as SAP validation and business use experience
If you are interested in this Software Quality Assurance Engineer III job in Rancho Cordova, CA then please click APPLY NOW. For other opportunities available at Adecco Engineering and Technology go to www.adeccousa.com.
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W-2 Candidates ONLY**
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