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>* ================================================================= *Urgent Requirement: Validation Consultant (OH)*
*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. *Urgent Requirement: Linux Firmware Developer (MN)* *Role : Linux Firmware Developer* *Work Location : Minneapolis, MN* *Duration of assignment (in Months) : 6-12 months* *Description:* • Strong expertise/experience in Linux package management/tools setup • kernel debugging • driver development • Application development. 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 "it req" group. To unsubscribe from this group and stop receiving emails from it, send an email to it-req+unsubscr...@googlegroups.com. To post to this group, send email to it-req@googlegroups.com. Visit this group at https://groups.google.com/group/it-req. For more options, visit https://groups.google.com/d/optout.
