Auto req 8304BR
Job Posting Title Sr Engineer
Career Category Quality
Employee Subgroup Salaried FT
Country (State/Region) United States - California
Location (City) Thousand Oaks
Amgen Job Description 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.
With general guidance, employee will work with process development and operations to ensure robust 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.
Experience with quality systems should include: ISO 9001: 2000 (ANSI/ISO/ASQ Q9001-2000), ISO 13485:2003 or related compliance regulations and management of engineering development procedures.
Employee will apply advanced 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.
Basic Qualifications - Doctorate degree
OR
- Masters degree & 3 years of directly related experience
OR
- Bachelors degree & 5 years of directly related experience
OR
- Associates degree & 10 years of directly related experience
OR
- High school diploma / GED & 12 years of directly related experience
Preferred Qualifications - BA/BS in Science, Engineering, or related field
- 7+ 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
