Edwards Lifesciences Senior Software Quality Engineer - Enterprise Computer System Validations in Irvine, California
The Senior Software Quality Engineer will be an essential member of the Software Quality organization. The candidate will report into the Software Quality Senior Manager responsible for Enterprise CSV & Manufacturing Systems SWQE functions. The candidate will execute SWQE activities to provide quality solutions and processes related to Enterprise Computerized and Manufacturing Systems used for GxP functions. This position will provide opportunities for advancement within our growing organization. We are looking for an ambitious candidate with a strong technical background, excellent communication skills (comfortable presenting to all levels of seniority), and the ability to build trusting relationships within the organization.
Responsibilities for success in this position include:
Support validation of enterprise systems (PLM, SCADA, SPC) in adherence to GAMP and GxP regulations
Author Validation Plans and Reports
Partner with leadership and cross-functional sites to create processes and procedures related to new emerging technologies supporting GMP operations, including IOT, Machine Learning and Artificial Intelligence Data-Driven technologies (Industry 4.0).
Working in close partnership with Global Supply Chain Validation, Automation and IT Teams to ensure enterprise software supporting manufacturing remains in a validated state and supports business needs.
Responsible for traceability of requirements and testing activities based on risk analysis.
Assist in software supplier audits.
Effectively manage priorities, multiple projects and ability to communicate at all levels of personnel.
Education and Minimum Requirements:
Must have a Bachelor’s degree in Sciences, Engineering, Computer Science, Software Engineering, Computer Engineering, or similar disciplines with 4 years of experience in Software Quality, I.T., or Equipment Software Validations; OR Master’s degree in same disciplines with 3 years of experience in Software Quality, IT, or Equipment Software Validations.
Experience working within medical device, pharma, or biotech industries.
Experience with manufacturing enterprise solutions (SCADA, SPC, PLM, or MES)
Experience in supporting software validation activities of PLM, SCADA, or SPC Systems
Familiarity with software automation or custom software used in manufacturing
Knowledge and experience in Quality Systems Risk Management (ISO14971) and GAMP solutions and processes
Experience in Manufacturing or Systems Software Quality, and/or Verification & Validations
Experience in implementing system solutions with IT or external suppliers.
Solution orientated, generates multiple innovative solutions.
Excellent written and verbal communication skills.
Highly detailed, interpersonal skills and ability to defend software quality assurance
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.