| Manufacturing Validation Engineer || Work Location : CA, Irvine, 92618 at Irvine, Kentucky, USA |
| Email: [email protected] |
| From: Khayal Abbas, Scalable- Systems [email protected] Reply to: [email protected] Job Title Manufacturing Validation Engineer Technical/Functional Skills Knowledge of Medical Equipment manufacturing processes GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs Ability to specify & qualify Assembly, Tooling, Gage equipment and Fixture equipment Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics Knowledge of biocompatibility in medical device industry Demonstrated ability to interpret the engineering drawings i.e., GD&T (Geometric Dimensioning &Tolerancing) Understanding of Process development & design and Quality Function Deployment Excellent Analytic problem solving, Broad business planning, Cross-functional integration skills Demonstrated understanding of Ergonomics and financial analysis skills preferred Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred Understanding of Marketing & market research strategies Personal computer skills, Windows: word processing, project planning, presentation, e-mail, web browsers & spreadsheet software Training & experience in Good Manufacturing Practices & ISO 9000 is required. Roles & Responsibilities Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are: Train mechanics & operators on internal processes & equipment requirements Perform Installation Qualification, Operational Qualification, Process Qualification Develop validation protocols, qualify first articles, complete process capability studies & process validation on both internal & supplier processes using appropriate statistical techniques Prepare reports as per project requirement Actively participate in setting overall project objectives, direction & contributing in other functional areas as needed Work with R&D as needed to support process development, process improvements and process transfer activities Can travel to plant site at Mexico if required Know & follow policies & procedures related to work activities performed in area of responsibility Complete training in area of responsibility within allowed time-period and periodic retraining in areas such as safety & environmental Follow all company safety policies & other safety precautions within work area. Work Location (State, City and Zip) CA, Irvine, 92618 Keywords: rlang California |
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| Mon Dec 04 19:10:00 UTC 2023 |