Quality Engineer OR Validation engineer

VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don’t consider the process complete until we find the perfect fit.

Job Description Of Validation Engineer:

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.

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.

Please fine the below job description of Quality Engineer.

Job Description:

·         Migration of CAPA, QI, Deviation, Audit, Supplier SCAR Modules from paper based system into Agile.

·         Create and maintain the Quality Plan for the migration project

·         Update Ionian CAPA, QI, Deviation, Audit, Supplier SCAR SOPs Policies, SOPs to align with Divisional and AQR SOPs.

·         Create trending and threshold procedure.

·         Create WIs to document  CAPA, QI, Deviation, Audit, Supplier SCAR processes using  Agile PLM functionality.

·         Determine impact to other Ionian SOPs and records, create new SOPs or update existing SOPs accordingly.

·         Migrate paper based open CAPAs into Agile, if applicable.

·         Create Training materials.

·         Train other Ionian employees.

·         Any other assigned responsibility related to the project.

Thanks and Regards,

Mohammed Ilyas,

PH - 229-264-4029.

All your information will be kept confidential according to EEO guidelines.