StaffWorks, LLC | Validation Engineer | poway, ca

6 days ago

poway, United States StaffWorks, LLC Full time

JOB PURPOSE


This position is responsible for leading site-wide process validations to assure compliance to Company, Customer, and ISO requirements. The Quality & Validation Engineer is responsible for directing and/or implementing validations and improvements on new and existing process often working with cross-functional team members (NPI, Quality Engineering, Manufacturing, Supply Chain and Sales/Marketing) focusing on the reliability of new and existing processes from NPI through production and delivery.


Responsibilities:


  • Collaborate with affected stakeholders to understand validation needs, and to develop validation plans for new products and existing processes.
  • Work with affected stakeholders to identify validation issues with the goal of continual improvement.
  • Analyze, derive, and allocate validation requirements, budgets, and targets for validations.
  • Facilitate and participate in Failure Mode and Effects Analysis (FMEA) of processes to drive reliable NPI and improve validation/verification test planning.
  • Provide input for validation requirements based on NPI review.
  • Develop validation strategies based on the QMS.
  • Develop and/or manage validation guidelines and apply lessons learned to enable continual improvement.
  • Create and maintain process validation plans and reports.
  • Manage and/or perform statistical data analysis following best practice/industry guidelines.
  • Coach engineers on the required validation activities, drive learning and meet project milestones.
  • Provides information to Risk Management anticipating validation-related safety hazards.
  • Work with supplier selection for high-quality starting stock and provide clear guidance on validation requirements for suppliers.
  • Perform all duties in accordance with business EHS standards at all times during working hours.
  • Escalate any safety or work-related issues to their team lead/manager that create risk(s) that might prevent them from performing their assigned duties and responsibilities in their role, within the Material Control Department, or at their work site.
  • May include limited travel requirements up to 10% of the time


Qualifications:


  • Certified ASQ Quality Engineer and/or bachelor’s degree in Engineering, Science, or technical discipline with 7+ years of quality, manufacturing, or other technical experience OR Advanced degree in Engineering, Science, or technical discipline with 5+ years of quality, manufacturing, or other technical experience
  • Demonstrated ability to perform effective validations in an ISO 13485/ 21 CFR environment
  • Proficient in data analytics, industrial statistics, (preferably using MiniTab)
  • Demonstrated ability to provide effective internal and external communication
  • Demonstrated ability to provide clear, concise written reports to internal and external customers
  • Demonstrated project management ability
  • 2-4 years’ experience in a job shop environment, preferably servicing the Medical Device Industry
  • Lean Six Sigma Green Belt (Black Belt preferred)
  • Proficient in Microsoft Office Suite

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