.**Responsibilities**:- Identifies the needs of information collection and uses the data to analyze problems or complex situations, using the appropriate tools, being able to generate suggestions and potential solutions with mínimal supervision, communicating effectively during the process.- Analyzes and provides direction, training and assistance to engineering and manufacturing groups on requests for documentation changes related to product configuration (Drawings, Specifications, List of Qualified and Unqualified Materials, Roadmaps, etc.)- Monitors product configuration changes (manual and electronic) to verify that the structure is correct and updates information in engineering, manufacturing, product management, control and business planning systems based on approved changes.- Develops a variety of routine tasks that are planned to provide experience and familiarity with the engineering team, methods, practices and programs.- Examines and interprets documents such as preliminary projects, drawings, change orders, specifications, etc. to verify the totality and accuracy of the data.- Resolves technical questions about quality assurances that support manufacturing processes.- Works under mínimal supervision on assignments that may include, but are not limited to: preparation of specifications, study of processes, research, preparation of reports and execution of tests.- Leads the verification and validation of systems that support manufacturing processes.- Shows knowledge and solid understanding of the processes and systems of the functional area, taking advantage of opportunities to continue acquiring and developing their experience.- Is able to work with staff from different functional areas, clearly communicate key system principles that support manufacturing processes, and works as a team in search of solutions for the business and make recommendations for improvements to systems and processes, based on lessons learned.- Is able to use medium complexity risk assessment tools in the development of solutions**Education and Experience Requirements**:- Minimum Bachelor's degree, preferably in Engineering or a related technical field.- Generally requires 4-6 years of related experience.- Experience working in both the FDA and European regulatory environment is preferable. This position requires relevant work experience in manufacturing/operations.- In-depth knowledge in product/process Risk Management (FDA and ISO standards) is preferable.- Experience with a proven track record of properly implementing risk mitigation.- Technical training and experience in the use of Statistics, and Lean and Six Sigma methodologies is preferable including Measurement System Analysis, SPC, DOEs, reliability, etc.- Strong knowledge of statistical software packages is preferable, with the ability to pre-visualize, graph and analyze data and be able to present data that facilitate decision making
