Hi Folks, Please share the suitable resource for this Position. Please share the Visa Copy and Photo ID Proof of your consultants. at *manish.gu...@nityo.com <manish.gu...@nityo.com>* =================================================================
*Role : Validation Consultant/ Project Quality Engineer* *Work Location : Cincinnati, OH* *Duration of assignment (in Months) : 12 months* *Relevant Experience(in Yrs) : 5-10 Years* *Technical /Functional Skills* The Supplier Quality Engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. He should also be able to: • Perform supplier evaluation and qualification • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. • Develop validation master plans, process flow diagrams, test cases, or standard operating procedures. • Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols. • Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards. • Conduct Designs validation study features, such as sampling, testing, or analytical methodologies. • Develop project plans for Validation/Qualification projects • Write master plans relating to any specified projects and conduct meetings to execute the validation plan. • Direct validation activities, such as protocol creation or testing. • Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment. • Adhere to all customer/company and GMP procedures, along with safety regulations within the workplace. *Experience Required* • A minimum of 5 years’ experience in a highly regulated industry is required. Medical Device and/or Pharmaceutical industry is preferred. • Experience in supplier evaluation and qualification • Strong knowledge of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effect Analysis (FMEA) • Lean Manufacturing knowledge • Understanding supplier manufacturing processes • Ability to work in a diverse and dynamic environment • Planning and prioritising activities • Good communication and interpersonal skills • Experience in interpreting graphs, charts, engineering diagrams, blueprints, shop orders, equipment guides and other instructions to solve problems. • Experience writing Functional Requirements, Design Specifications, FAT’s, SAT’s, IQ’s, OQ’s, PQ’s. • Experience executing FAT’s, SAT’s, receipt verification, IQ, OQ, PQ. • Experience using scientific rules and methods to solve problems. • Experience in identifying complex problems and developing and evaluating options and implementation of solutions. • Should have knowledge of Process and Product Validation requirements and techniques. • Excellent problem solving and decision-making skills will be required. Interpersonal skills that foster conflict resolution as it relates to technical situations will be required. • Process validation experience is required. *Roles & Responsibilities* *• Authoring and approving IQ/OQ/PQ document* *• Authoring and approving engineering study* *• Authoring and approving test methods* *• Supplier evaluation and qualification* • Execute & report all validation activities including analysis (DQ / IQ / OQ / PQ / PPQ / PFMEA) • Work with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements • Facilitate root cause analysis and corrective actions of supplier quality issues • Collate and evaluate supplier quality data to identify process improvement opportunities within the supply • Work with the supplier directly, create correction action plans to address process failures • Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities • Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements • Support and lead process improvement activities at the supplier place. • Review and provide solution for rejection and prepare QC and production report. • Prepares, maintains, or reviews validation and compliance documentation, such as engineering change notices, schematics, or protocols. • Ensure compliance to the laid down quality system requirements and ISO 13485 standards. • Studies product characteristics or customer requirements and confer with management to determine validation objectives and standards. • Directs validation activities, such as protocol creation or testing. • Prepares validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment. • Work with other teams/departments to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges *Generic Managerial Skills* Supplier Quality Engineer will assume the role of team leader and organize QA and other departments to achieve the successful introduction of new products, including: • Handling several projects concurrently • Meet delivery promise in terms of budget and timescales. • Work within a multi-discipline team, consisting of the R&D Development Group, Marketing, Quality, Operations, etc. Thanks & Regards! *Manish Gupta* *Desk : **609-853-0818 **Ext. 2130* *Email : manish.gu...@nityo.com <manish.gu...@nityo.com>* -- You received this message because you are subscribed to the Google Groups "US_IT_ Jobs" group. 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