One Amgen Center Drive Thousand Oaks, CA 91320
As a member of the 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 assignments as given.
With general guidance, employee 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.
Experience with Quality systems should include: ISO 13485 or FDA CFR 820.30 related compliance regulations and management of engineering development procedures.
Employee will develop, organize, analyze, present and implement results for operational issues or engineering projects of moderate scope and complexity.
TOP 3 SKILL SETS:
(1) Understanding of design controls
(2) understanding of CAPA/NC and relevant procedures
(3) Quality engineer be able to work with minimal oversight, critical thinking.
(4) Experience with electromechanical devices and device development.
- BA/BS in Science, Engineering, or related field
- 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
- 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