Katalyst Healthcares and Life Sciences
Responsibilities:
- Quality Engineering is responsible for product and service quality evaluation and control.
- Works cross-functionally in the development and or maintenance of products or services.
- The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials, /and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
- Demonstrates basic knowledge of quality engineering policies, principles and best practices.
- Demonstrates basic knowledge of FDA/ISO requirements.
- Apply basic statistical sample size calculations to work for quality determination on simple projects.
- Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision.
- Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended.
- BS Degree or equivalent.
- Must have on the resume GMP experience in med devices and or pharma, Supplier Quality a plus.
- 2 years' applicable experience.
- Having basic knowledge of theories, practices and procedures in a job family or skill Applies knowledge and skills to complete own work Depends on others for instruction, guidance and direction.
- Develops competence in own area by performing routine work.