Abbott Quality Engineer in Alameda, 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.
Serve as the QA representative on on-market development / change teams for Abbott's FreeStyle Libre and FreeStyle Libre Pro products
Monitor design control related projects: Project planning issues, Compliance Activities (DHF Audits, Traceability, etc.), Verification and Validation Status
Participate in continuous improvement initiatives as appropriate for the design control system
Build and maintain successful cross functional relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs
Provide support, as needed, to Clinical Material Release, Quality Control, and Calibration programs
Additional Main Responsibilities:
Assist in the development, approval, and change control of design history documentation (e.g. Design Inputs, Design Outputs, Trace Matrix, Design Verification/Validation, Change Impact Assessments, Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.)
Monitor and maintain DHF requirements in accordance with project timeline and design control requirements
Actively engage with Operations and Engineering to implement design control deliverables
Bachelor’s Degree in one of the following areas: Engineering Life Sciences, or Physical Sciences. 2 years of experience in Quality Assurance, Technical Quality, or equivalent; Knowledge in the areas of Design Controls, VV activities, manufacturing practices or processes, and statistical techniques. Working knowledge applicable regulations and standards such as FDA, QSR and ISO regulations. Demonstrated written, oral and interpersonal skills. Strong analytical skills, problem solving techniques and statistical application experience.
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 email@example.com