Engineer I, Quality - CR
Position Overview
Support the development and manufacture of medical devices. Work with Manufacturing and R&D to resolve product quality issues. Support manufacturing process changes, product design improvements, and the implementation of new products. Job duties:
- Support R&D and Quality Engineers with design validation and design validation testing of new products.
- Support R&D and Quality Engineers in preparing quality specifications and receiving specifications.
- 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 the manufacturing of 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 System 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.
- Bachelor’s degree in engineering or related field of study.
- Minimum one (1) year of experience in the medical device industry as an Engineer or related experience.
- Strong written and verbal communication skills.
- Computer skills including MS Word, Excel, Outlook, and Teams, with the ability to learn Statistical Software (MiniTab, Statgraphic, Design of Experiment DOE).
- Good writing, speaking, and listening skills in English.
- Some related industry experiences desirable.
- Knowledge of medical product manufacturing.
- Ability to understand the technology related to the Company’s products.
- Knowledge of medical product quality assurance.
- Good mathematics skills.