Title: FDA Quality Consultant
Location: Neenah WI 54956
Duration: 4 Months
Provides Quality/Regulatory support for Post Market Surveillance team while ensuring compliance to established procedures and processes – including complaint handling and adverse event reporting.
General Expectations and Accountabilities:
- Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.
- Manages self in accordance with the expected behaviors of the Leadership Qualities.
- Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
- Maintain and demonstrate an appropriate level of knowledge and skill in quality systems, processes, and regulations.
- Establish and maintain good customer rapport. Develop and maintain a strong spirit of partnership.
- Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know.
- Capability in Quality Management Systems, ISO, and GMPs to support activities.