Amgen Senior Quality Device Engineer in Cambridge, Massachusetts
As a member of Amgen's Commercial Quality group for drug delivery, this position will provide engineering support for new product development and ensure design control systems are followed in the creation of new drug delivery devices.
Responsibilities include participation in Corrective and Preventive Action projects; responsible for documentation related to investigation of product complaints, trending of quality data, and other assignments as given.
The Quality Engineer will work with drug delivery and operations to ensure robust device designs are validated, qualified and launched. In addition to new development the responsibilities will include working on cross functional teams to understand product inquiries, reduce complaint rates and provide support for troubleshooting operational issues and capital projects.
Position will apply engineering principles to the design and implementation of system modifications and/or capital projects. Employee will develop, organize, analyze, present and implement results for operational issues or engineering projects of moderate scope and complexity.
Master's degree and 3 years of Quality, Engineering or Operations experience
Bachelor's degree and 5 years of Quality, Engineering or Operations experience
Associate's degree and 10 years of Quality, Engineering or Operations experience
High School diploma / GED and 12 years of Quality, Engineering or Operations experience
BA/BS in Science or Engineering
5+ years of Quality or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in validation, investigations and/or change control
Experience with quality systems including: 21CFR Part 820, Part 4 Combination Products, Medical Device Directives (MDD), ISO 13485:2003
Knowledge of Design Controls
Hands on experience with Research and Development procedures
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
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.