Vacancy expired!
- Create Device Master Record (DMR) and Device History Record (DHR) process. Document accordingly.
- Labeling: Work with process engineering to develop and document UDI labeling.
- Validation: Work with process engineering to validate all equipment and processes related to FDA programs. This includes fixtures.
- Identification: Work with maintenance to identify and log all tooling and/or fixturing for the FDA related programs.
- Line clearance: Update the line clearance process to ensure it is in compliance with FDA requirements.
- Calibration: Assist in determining which items do and do not require calibration and label/document accordingly.
- Quality System: Work with all departments to ensure compliance to ISO13485 and FDA 21 CFR820 requirements. Perform internal audits as required.
- BS Degree in Engineering or other related field
- At least 1 year of Quality Experience with respect to FDA 21 CFR 820 requirements
- Experience with analysis and documentation
- 3+ years' experience in Quality Engineering in an FDA related environment
- Working knowledge of electronic assembly, testing, molding, and stamping processes
- Experience with Quality Systems (ISO 9001, ISO13485, and/or TS16949)
Vacancy expired!