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Urgent Requirement of Validation Engineer at San Diego, CA (Onsite)

Hi

This is Sumit and I represent Quantum World Technologies Inc., a leading IT staffing organization. I came across your resume in one of the job boards and would like to draw your attention to an open contract position, requirement details are given below: If interested, please share your updated resume ASAP.

Position Title: Validation Engineer

location: Location – San Diego, CA (Onsite)

Duration: 8-12 Months Contract

Job Description:

Responsibilities:

  • 2-3 Years’ experience Combination of Mechanical & Manufacturing, with Medical Devices background.
  • Extensive experience in Facilities, Utilities and Equipment validations
  • Create Master Validation plan (MVP)  in coordination with different stakeholders
  • Hands on experience in Method Transfer, Process Validation (IQ /OQ /PQ), Validation performance and Reports.
  • Working on sample size determination, creating sample size for Testing’s, for Design Verification, Validation, Process Validation and Test Method Validation
  • Hands on experience working on Validation reports for the Manufacturing site that are moving from one place to another. This includes Facility Validation as well.
  • Hands on experience on drafting Protocols, Testing, Data Analysis and Test Reports
  • Extensive Experience on using Minitab for Data Analysis, R&R Analysis after Test Execution
  • Understanding on Software elements would be an added advantage
  • Knowledge on IVDR and DHF Remediation also will be an added advantage
  • Good understanding on Requirements analysis (Customer Reqs, Technical Reqs, Functional /Product Reqs), Traceability Matrix, DHF Remediation and Risk Management with FMEA working.
  • Experience with QC Tools and Statistical Methods
  • Understand Product BOMs and Assessment with reference to information available in PLM/Other Repository
  • Working closely with customer counterparts and understanding their Requirements and working on collaborative mode. Understand the customer requirements and suggest alternative feasible concepts.
  • Good knowledge in various manufacturing process like Machining, Sheet Metal, Plastics and DFM/A.
  • Familiar with Engineering Change Orders and Engineering Change Notes
  • Proven track record of problem solving
  • Knowledge in Mechanical Design, Bill of Materials, Product Life Cycle stages
  • Provide Project status updates to the work group, tracking the overall project implementation.
  • Good Communication and documentation skills. Good knowledge in MS PowerPoint and Excel

 

Regards,

Sumit Bhatnagar

Team Lead

Quantum World Technologies Inc.

199 West Hillcrest Dr Suite # 0112, Thousand Oaks CA – 91360

www.quantumworld.us

Contact: (805)-222-0532*347

E: sumit.bhatnagar@quantumworld.us

 

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