One Amgen Center Drive Thousand Oaks, California 91320 | Contract
This position will provide quality engineering support for both new product development and sustaining to ensure design controls are followed in the creation of drug delivery devices in the Quality organization.
The qualified candidate will employ quality principles and company’ s procedures to ensure development and sustaining of these mechanical and electro-mechanical medical devices complies with applicable regulations and standards. The Quality Engineer will work within cross-functional project teams to develop and maintain detailed engineering specifications, support device design & development, design verification/validation, to provide technical expertise and represent Quality functions and needs.
Master' s Degree
Bachelor’ s degree and 3 years of Quality, Engineering or Operations experience
BS in Engineering and previous experience in medical device industry
3-5 years of Quality, Engineering or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience
Experience with quality systems including: 21 CFR 820, Part 4 Combination Products, Medical Device Directives (MDD), ISO 13485 and ISO 14971
Knowledge of Design Controls
Experience with product design enhancements/improvements
Experience in interacting with regulatory agencies
Good written and verbal communication skills
Ability to interpret and apply regulatory and quality requirements
Ability to work independently as well as on teams
Ability to prioritize and manage multiple tasks
Ability to work in a challenging and fast-paced work environment