One Amgen Center Drive Thousand Oaks, California 91320 | Contract
Top 3 Must Have Skill Sets: Understanding of design control DHF audit DHF remediation Ability to work in teams
Basic 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
Preferred Qualifications - 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
Experience with quality systems should include: ISO 13485: 2003 or related compliance regulations and management of engineering development procedures.
Job Description: This position will provide engineering support for design history file review and remediation, new product development and ensure design control systems are followed in the creation of new drug delivery devices.
Responsibilities include: review and remediation of design history files, 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 device technologies and operations to ensure robust designs are good quality design history files, adequate validation, qualification and launch of a drug device combination product.
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.