Abbott Development Quality Engineer I in Sylmar, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies 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 than 150 countries we serve.
The Development Quality Engineer assures new or modified test systems conform to internal design requirements and quality standards , as well as establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Support quality activities ensuring automated test verification and validation planning, execution, and deliverables comply with quality system regulations
Responsible for running compliance and/or performance tests as needed to ensure delivery of a test system, and conducting cross-functional root-cause analysis investigation and issue resolution activities
Support on-time execution of Quality Plans for internal development, OEM-based, and design change projects
Support design test and inspection method development, and execute method validation activities
Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support manufacturing process development & qualification for new product commercialization and product changes
Support global test system implementation at multiple manufacturing sites through remote access Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Complete Document Change Request Reviews in a timely and objective manner
Additional duties may be identified by functional management based on the current project/business objectives.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor level degree in Electrical Engineering or Technical Field, advance degree or degree in Electrical or Computer Engineering preferred
0-3 years experience (experience in software coding and test experience engineering preferred)
Solid communication and interpersonal skills
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrix and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org