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Job Description: Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the companys systems and procedures to optimize product development, internal and external device manufacturing, and device distribution. Investigate basic manufacturing product quality and compliance issues (e.g., CAPA (Corrective and Preventive Action), non-conformances, and audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, and develop reports. Optimize manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for Design For Manufacturing and for Continuous Process Improvement. Identify opportunities for re-design or design of basic equipment, tools, fixtures, etc., to improve manufacturing processes and reduce risk. Develop, update, and maintain technical content of risk management files. Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes. Instruct and train technicians on conducting tests.

Minimum Requirements: Bachelor's or degree equivalent in Engineering (Bioengineering, Chemical, Manufacturing, or Mechanical) or related field and 2 years of experience in the job offered or in quality systems, quality engineering continuous improvement, medical device corrective maintenance, or a combination of these fields; exp. must be w/i the medical device or healthcare industry. Work experience to include: Using CAPA, non-conformances, and audit processes to investigate manufacturing product quality and compliance issues for all production processes prior to final medical product release; analyzing results, making recommendations and developing reports. Optimizing manufacturing processes for medical devices using SIX Sigma, statistical techniques (sampling plan and process capability (CPK)), and LEAN methods for Design For Manufacturing and for Continuous Process Improvement. Updating tools and fixtures to improve manufacturing processes and reduce safety risks for medical devices. Updating and maintaining technical content of risk management files (Failure Mode and Effects Analysis(FMEA), risk analysis, and Risk Management Worksheet (RMW)). Updating and maintaining training and documentation materials for production of medical devices (work instructions and Standard Operating Procedures (SOP)) to enable knowledge transfer of project and manufacturing processes; must include providing training for Front End Employees (FLE). Instructing technicians on conducting inspection equipment validation (Installation Qualification), preventive maintenance, and repairs. Establishing project plans to ensure deliverables are completed to customers specifications using project management tools (Risk Analysis and project management software). Applying knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and internal and external medical device manufacturing guidelines.