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
General Expectations and Accountabilities:
1) 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.
2) Manages self in accordance with the expected behaviors of the Leadership Qualities.
3) Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
4) Maintain and demonstrate an appropriate level of knowledge and skill in quality systems, processes, and regulations.
5) Establish and maintain good customer rapport. Develop and maintain a strong spirit of partnership.
6) Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know.
7) Capability in Quality Management Systems, ISO, and GMPs to support activities.
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.
This position reports to Senior Quality Manager – QMS and Post-Market Surveillance. Has responsibility for execution of and record-keeping for quality systems in support of regulated products. Carries out routine workload and small system improvement projects with minimal direction, but asks for assistance/guidance when appropriate.
Normally requires a Bachelor’s degree in science, engineering or related discipline and/or 5+ years broad experience in Complaint Handling/Post Market-Surveillance or related filed. Knowledge of Medical Device requirements (e.g. ISO13485, 21 CFR 820 and 21 CFR 803) is preferred.