Roles & Responsibilities:
- Bachelors Degree in an Engineering discipline from an accredited institution required.
- Complaint product analysis and testing per procedures and requirements.
- Root cause analysis and supports conclusions with objective evidence and sound rationale. Complaint risk analysis and complaint history reviews.
- Knows and applies Quality System requirements and any appropriate FDA and international standards.
- Must have an understanding of root cause and risk analysis as well as technical writing.
- Previous experience in the Medical Device or Pharmaceutical FDA regulated environment required.
- Product complaint investigation and handling.
- Experience with FDA/ISO quality management system regulations.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract