As a member of Amgen's Commercial Quality group for drug delivery systems, this position will provide Quality 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 Design development, Design control per FDA CFR 820.30, Corrective and Preventive action projects; responsible for documentation related to investigation of product complaints, trending of quality data and other projects as assigned.
The Principal Quality Engineer will work with Process Development and Operations to ensure robust designs are verified, 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.
This position will develop, organize, analyze, present and implement results for operational issues or engineering projects of moderate scope and complexity.
Doctorate degree and 2 years of Engineering, Device or Quality experience
Master's degree and 6 years of Engineering, Device or Quality experience
Bachelor's degree and 8 years of Engineering, Device or Quality experience
Associate's degree and 10 years of Engineering, Device or Quality experience
High school diploma / GED and 12 years of Engineering, Device or Quality experience
BA/BS in Science or Engineering
10+ 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 should include: ISO 13485 or FDA CFR 820.30 related compliance regulations and management of engineering development procedures
Understanding of design controls, Corrective Actions / Preventative Actions and Non-Conformances as well as the ability to interpret and apply regulatory and quality requirements
Ability to work both independently and in teams while applying critical thinking
Experience with electromechanical devices and device development, including product design enhancements/improvements
Experience in interacting with regulatory agencies
Good written and verbal communication skills
Ability to prioritize and manage multiple tasks, 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.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.