Multiple Requirement: Validation Consultant/Project Quality Engineer & Linux Firmware Developer

Hi Folks,
Please share the suitable resource for this Position. 
Please share the Visa Copy and Photo ID Proof of your consultants. at Manish.gupta@nityo.com
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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

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