Associate Post Market Surveillance Engineer

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 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 providing guided assistance 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. You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. 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 supporting complaint investigation activities with cross functional team members and sending complaint investigation reports. You will interface with internal and external customers to gather additional information required for complaint investigations and assist in preparing customer communication, as applicable. You will assist in the data collection, root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety. You will support timely closure of complaint investigations to comply with FDA requirements and other regulatory bodies and countries. You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support in your development and a Post Market Surveillance Engineer. Audit Support: You will assist in internal and external audits by compiling and organizing complaint data. You will be mentored to participate in internal audits. Quality System Responsibilities: You will perform work on projects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements. 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 an Associate Post Market Surveillance Engineer. You embed Quality 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 differentiated quality. You may perform other duties as needed and as directed by your line of supervision. Integer’s Manufacturing Excellence and Market Focused Innovation Strategies: Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies Participation or Leadership in Site Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives Provide leadership as required for QA/RA weekly and monthly metrics, supporting the journey to differentiated quality.   Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required. Support the standardization of workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable. Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and improvement idea and suggestion systems. Systems & Process Optimization through adoption of principles of built in quality,  How you will be measured:  The specific measures listed below may be subject to change and are not intended to be an all-inclusive list. Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs. Adhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation. You will have defined Goals and Objectives specifying key projects and expected milestones to achieve. Achievement of site quality KPI’s. Innovation and ideation are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support the implementation. What sets you apart: Minimum Education and Experience : You have earned, as a minimum, an Associate’s or two-year degree and have between 0-3 years of experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years’ relevant experience such as organizing and accurately controlling large amounts of detailed information and product handling. Specialized Knowledge: While you will have regular support and guidance from more experienced Post Market Surveillance professionals, supervisors, or man