Post Market Surveillance Engineer II

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right What you'll do in this role: The primary purpose of this job is to execute and support the Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes for Integer under the direction, instruction and guidance from more experienced associates and managers in your organization. This position will be responsible for executing and providing support in the analysis, evaluation and product investigation of complaints received from external customers in a timely manner to comply with FDA 21 CFR (QSR) requirements and requirements of other regulatory bodies and countries with some instruction and guidance from more experienced associates and managers . Post Market Complaint Handling Activities: You will be responsible for accurately capturing and documenting all complaints in the complaint handling database according to internal policies and procedures. You will be responsible for sending complaint acknowledgements to customers. You will be responsible for tracking customer return products. You will be responsible for performing complaint investigation activities with cross functional team members . You will be responsible for reviewing device history records for nonconformities related to the alleged complaint . You will interface with internal and external customers to gather additional information required for complaint investigations and prepare customer communication, complaint investigation reports and Customer Facing Reports, as applicable. You will execute data collection, root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety. You will play an active role in ensuring timely closure of complaint investigations to comply with requirements of FDA and other regulatory bodies and countries. You may be required to handle, decontaminate, and analyze products used in the field by hospitals/end users per internal procedures and safety requirements, which will require you to have relevant vaccinations. You will be responsible for performing risk assessments for products that are Integer owned designs. You will be responsible for performing CAPA assessments and supporting CAPA investigations. You will be responsible for assessing Adverse Event Reportability decisions in accordance with US and International regulations . You will be responsible for assisting in the completion of applicable forms for submission of reportable complaints to applicable agencies. You will assist in gathering complaint and ship data to support Post Market Trending, PMSRs, and PSUR's. You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support in your development as a Post Market Surveillance Engineer II . Audit Support: You will be responsible for supporting internal and external audits. Provide support for external regulatory inspections and customer audits. Support the timely response and closure of audit observations and findings . Quality System Responsibilities : You will p erform work on project s where you will follow Integer's standard quality management system methodologies to investigat e opportunities for process improvement s. You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as a n Associate Product Surveillance E ngineer . You embed Q uality within the Regulatory discipline - "I own Quality." You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI's and journey to 5 Sigma. You may perform other duties as needed and as directed by your line of supervision. Manufacturing Excellence Imperatives : Provide support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies Participation or Leadership in Site Hoshin Planning, Quality Planning, Val #J-18808-Ljbffr integer