Title: Quality Consultant II
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.
Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Legal, Marketing, Consumer Services
Position Specific Accountabilities:
1) Executes assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Final Review, Sample Evaluation, and Flow to Work to assist others as needed.
2) Perform Decision Tree Determination and drafting of adverse event reports for regulatory.
3) Achieves and maintains required competence level for Medical Device Reporting.
4) Maintains relationships with Consumer Services, including reporting of errors, troubleshooting, and coordinating complaint handling activities and improvements.
5) Helps execute CAPAs and QNCs.
6) Complies with QMS, ISO, FDA GMP's, and Health Canada requirements.
7) Provides Post-Market Surveillance support to Mills and/or Product Forms via Standard Work, data analysis, and communication.