Validation Engineer (Test Method Validation – Medical Deivce) – REMOTEOPPORTUNITY

Validation Engineer (Test Method Validation) – Medical Device Insdustry

Start Date: October 11th

Duration: 9 months initial duration with potential for work through 2023.

Our client in Bloomington, IN is looking for a Test Method Validation Engineer that can work a hybrid role 50% on site with full expenses covered and 50% remote.

Project Details:

Our medical device client on the east coast is in need of a Test Method Validation Subject Matter Expert to help with a legacy prodcut remediation program.

Primary responsibilities include:

  • Review legacy products and apply accurate TMV standards
  • Establish standard best practices
  • A background in metrology is a bonus
  • Training / mentoring junior leve engineers

Additional responsibilities may include:

  • Run process qualifications including Instillation Qualification, Operational Qualification and Performance / IQ OQ PQ.
  • Develop, design and execute validation protocols
  • Review and approve engineering change control, plant validation protocols and reports
  • Establish, coordinate and act as subject matter expert for the site’s Master Validation Plan, schedule, execution of schedule, validation police and practice
  • Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.
  • Lead Engineering team in the qualification of new equipment for inspection, including development and validation of routines for automation of complex visual inspection systems.
  • Perform training to procedural and quality system changes.
  • Facilitate Risk Management process in compliance to appropriate external standards and corporate policies.
  • Drive Quality Engineering activities designed to improve customer satisfaction and achievement of company quality objectives.
  • Has advanced knowledge in the areas of Quality Assurance, Process Validation, Design Controls, Risk Management and Statistical Techniques.
  • Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.

***FOR IMMEDIATE CONSIDERATION, please submit your contact information and resume.

Qualified candidates will be contacted immediatley. No 3rd party vendors please.

Thank you for your interest in Treximo!

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