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.
Manufacturing Support
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
You will monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
You will review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
You will participate in continuous improvement projects.
You will assist with product transfers.
You will perform work on technical projects where you will follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and 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 engineer.
Create Test Methods
You will Lead the generation and completion of protocols and reports for test method validations.
You will interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
You will develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval, and implementation of Incoming, In-Process and Final Inspection procedures.
Support Non-Conforming Material Process
You will ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence.
You will lead and manage complaint investigations.
You will participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
You will apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements to products and processes.
