Mechanical Engineer, Validation Engineering
1 year min subjected to extension.
Irvine, CA,92618
Relevant Experience
(in Yrs) 6 - 8 years
Technical/Functional Skills
• Strong Mechanical engineering skills with working knowledge of: process/equipment validation activities, product design, design verification, etc.
• Expert knowledge of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Knowledge of writing validation protocol, planning and designing test method, etc.
• Knowledge of statistical analysis tool, like Minitab is required.
• Excellent written and oral communication skills.
• Ability to use problem solving techniques including root cause analysis and cause and effect analysis, Statistical techniques and methods.
• Experience in medical device design and development is preferred. Working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and risk management tools, such as, Risk Analysis, FMEA and FTA.
The qualified candidate for this hands-on position should be able to use Mechanical Engineering principles, tools, and practices to determine process/equipment validation requirement and develop validation protocol and perform validation activities (IQ/OQ/PQ) that are aligned with the overall business and quality vision. The individual must be capable of working independently and in a team setting supporting different process/equipment validation activities.
Experience Required 6-8 yrs
Roles & Responsibilities Major responsibilities include:
• Understand and develop validation requirements, write validation protocols, perform different validation activities, like IQ, OQ, PQ, etc.
• Initiate, complete and support validation activities (IQ/OQ/PQ) for different equipments.
• Make technical decisions on product/process validation and guide the team towards their goals of reducing non-conforming components and drive reliability improvements.
• Lead, support and complete verification/validation activities, and product and process improvement activities. Able to conduct reviews, presenting results of formal analysis, generating project progress reports and investigation summaries.
Ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product, meeting its current specifications and quality attributes.
Generic Managerial Skills Able to coordinate with cross functional team, Good communication skill
Education Mechanical Engineer.
1 year min subjected to extension.
Irvine, CA,92618
Relevant Experience
(in Yrs) 6 - 8 years
Technical/Functional Skills
• Strong Mechanical engineering skills with working knowledge of: process/equipment validation activities, product design, design verification, etc.
• Expert knowledge of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Knowledge of writing validation protocol, planning and designing test method, etc.
• Knowledge of statistical analysis tool, like Minitab is required.
• Excellent written and oral communication skills.
• Ability to use problem solving techniques including root cause analysis and cause and effect analysis, Statistical techniques and methods.
• Experience in medical device design and development is preferred. Working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and risk management tools, such as, Risk Analysis, FMEA and FTA.
The qualified candidate for this hands-on position should be able to use Mechanical Engineering principles, tools, and practices to determine process/equipment validation requirement and develop validation protocol and perform validation activities (IQ/OQ/PQ) that are aligned with the overall business and quality vision. The individual must be capable of working independently and in a team setting supporting different process/equipment validation activities.
Experience Required 6-8 yrs
Roles & Responsibilities Major responsibilities include:
• Understand and develop validation requirements, write validation protocols, perform different validation activities, like IQ, OQ, PQ, etc.
• Initiate, complete and support validation activities (IQ/OQ/PQ) for different equipments.
• Make technical decisions on product/process validation and guide the team towards their goals of reducing non-conforming components and drive reliability improvements.
• Lead, support and complete verification/validation activities, and product and process improvement activities. Able to conduct reviews, presenting results of formal analysis, generating project progress reports and investigation summaries.
Ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product, meeting its current specifications and quality attributes.
Generic Managerial Skills Able to coordinate with cross functional team, Good communication skill
Education Mechanical Engineer.
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