| Urgent Requirement for Manufacturing Validation Engineer - Irvine, CA at Irvine, California, USA |
| Email: [email protected] |
| From: Narsimha Kathi, iTech US [email protected] Reply to: [email protected] Hi , We have a job opportunity for you, please find the below details and let me know your interest ASAP. Role: Manufacturing Validation Engineer Location: Irvine, CA Duration: Long Term Contract Responsibilities: Manufacturing Validation Engineer 4+ years of experience & demonstrated proficiency in manufacturing validation & providing ongoing technical support is preferred with evidence of continued self-development. Work experience in the Medical Device industry. 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. Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language. Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Ability to understand and follow complex written procedures is required. A minimum B.Sc. in Engineering or B-Tech in Mechanical Engineering with 4+ years of related experience manufacturing process validation SUBMISSION DETAILS LinkedIn: Consultant Name: Current Location: Relocation (Yes/No): Highest Qualification: Year/College/University: Thanks & Regards Narsimha Kathi iTechUS, Inc Direct: 802-735-0270 Phone: 802-383-1500 Ext 141 Keywords: rlang California South Carolina |
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| Tue Dec 05 00:29:00 UTC 2023 |