Associate Engineer, Quality - CR
Position Overview
Support the development and manufacture of medical devices. Work with Manufacturing, Production, and R&D to resolve product quality issues. Support manufacturing process changes, product design improvements, and the implementation of new products. Job duties:
- Support Manufacturing and R&D Engineers with validation related to processes or products.
- Support Manufacturing and R&D Engineers with testing of new products.
- Support Manufacturing Engineers with transfer related activities.
- Support R&D and Quality Engineers in preparing quality specifications.
- Coordinate and support labeling reworks.
- Manage X-level documentation.
- Conduct test method validations.
- Coordinate implementation of new equipment by preparing equipment specifications and by participating in installation qualifications and operational qualifications.
- Support Manufacturing and Production of actual and new products.
- Support various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
- Comply with applicable Laws and Regulations, adhere to Quality Management Systems processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- 60% at minimum degree in Engineering or a related field.
- Minimum one (1) year of experience as an Engineer or related experience.
- Good written and verbal communication skills in Spanish and English.
- Knowledge of medical product manufacturing.
- Ability to understand the technology related to the Company's products.
- Knowledge of medical product quality assurance.
- Computer skills including MS Word and Excel, with the ability to learn Statistical Software (MiniTab, Statgraphic, Design of Experiment DOE).