BrightOwl Loader Loading

Sr. Validation Quality Engineer - United States  

Company managed [?] Still accepting applications

Posted on : 30 June 2017

Project Description

Summary:  
  • Responsible for the development and oversight of the Quality System validation program at the site. 
  • Develops and executes IQs, OQs and PQs for manufacturing and quality systems software and process validations. 
  • Reviews existing processes and software for compliance to medical device validation requirements and reports/mitigates any gaps. 
  • Develops in-depth knowledge of products, manufacturing processes, and software used in the process and in quality systems. 
  • Works with the Supplier Quality team to review supplier validation processes/documents.   


Duties and Responsibilities:   
  • Develop and execute IQ, OQ, and PQ validation protocols for production processes, equipment and software, as well as quality system software. 
  • Develop and execute test method validations for process and product testing. 
  • Write reports summarizing results for equipment, process or software validation projects. 
  • Review existing validation reports and identify/mitigate gaps for compliance to requirements 
  • Review supplier validation programs,processes and documentation and support improvements. 
  • Conduct or lead corrective and preventive actions in quality systems or validations using problem solving techniques. 
  • Conduct or lead internal and supplier audits of validation programs and processes. 
  • Develop understanding of production processes and production software/inspection software to support continuous improvements or corrective/preventive actions. 
  • Participate as an active new product development core team member 
  • Support quality system projects and activities such as engineering change order support and complaint investigation support. 
  • Support FDA inspection readiness activities. 
  • Perform other duties as assigned.  

 

 Job Requirements : 
 Qualifications:   
  • Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 5-8 years of process/software validation experience in medical device industry 
  • Experience in the medical device industry in the development and deployment of quality systems, validations, process controls and continuous improvement methods.  


 Knowledge, Skills & Abilities:   
  • Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD) 
  • Proficient in root cause analysis, verification & validation, process flow mapping 
  • Experience with scientific instrumentation in a design and manufacturing environment 
  • Independent problem solving skills 
  • Computer proficiency with background in Agile and SAP business information systems a plus 
  • Energetic, results-driven with excellent organizational and prioritization skills. 
  • Excellent written and verbal communication skills and highly effective time management skills. 
  • Ability to operate independently and as part of a team 
  • Commitment to continuous improvement principles.