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Sr. Validation Quality Engineer Hopkinton United States,  

Posted on : 30 June 2017

Project Description

Job Type : Full Time Career Level : Experienced (Non-Manager) Education : Bachelor's Degree Location : Hopkinton MA US Job 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.


Hopkinton MA US

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