Job Description Quality Engineer – Post Market Neenah, WI Position Purpose Provides QualityRegulatory and Medical ProfessionalTechnical support for assigned quality systems, executing systems transactional work, routinely checking for compliance with standards, and providing limited training. Customers Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research Engineering, Packaging, Legal, Marketing, Contract Manufacturers, Consumer Services, Clinical Affairs, Regulatory Agencies, Consultants. 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. Effectively achieve results that meet business and individual objectives. Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed, as applicable. Performs production and quality systems audits. Maintain and demonstrate an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations. Establish and maintain good customer rapport, while driving solutions to meet business needs. 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. Executes continuous improvement activities for established processes and initiatessupports development of new processes. Builds and maintains capability in QMS, ISO, and GMPs to support objectives. Work results have the ability to influence longer-term product or functional decisions Requires independent completion of work, where judgment and discretion is required within the boundaries of the Post Market Surveillance end to end process Position Specific Accountabilities Execute assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, TrendingReporting, Decision Tree Completion, Final Review, and Sample Evaluation. Flow to Work to assist others as needed. Act as the owner of one or more quality sub-systems (within Post-Market Surveillance), making recommendations and decisions on changes to standards, providing training to users, and supporting implementation as needed. Identifies need for, develops, and executes continuous improvement plans for the assigned sub-system(s) to deliver business results. Builds and maintains capability within the assigned sub-system for compliance with QMS, ISO, and FDA GMP’s. Responsible for providing Post-Market Surveillance support to assigned Mills andor Product Forms via Standard Work, data analysis, and communication. Responsible for completing Level 1 2 Complaint Investigations on behalf of Mills. Initiates and follows up on CAPA and QNC related to the assigned system. Provide medical insight to assigned brands as well as supporting team requirements for preliminary medical assessment. Align opinions with Product Safety and Senior Medical Officer and escalate as needed. Scope This position reports to SR. Quality Manager Post-Market Surveillance Consumer Services. Has responsibility for execution of and record-keeping for quality systems in support of regulated products, with an emphasis on evaluating complaints using medical technical knowledge and escalatingcommunicating accordingly. Has responsibility for continuous improvement of quality sub-systems in support of regulated products, and leads small to moderate-sized improvement projects. Hours 800am to 500pm Education Additional Job Details