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Quality Engineer - Validation, Change Control

Company: Thermo Fisher Scientific
Location: Eugene
Posted on: February 14, 2019

Job Description:

Job Title: Quality Engineer-Validation & Change Control Requisition ID: 85939BR

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Position Summary The Quality Engineer (QE) is responsible for management and oversight of all validation and quality engineering activities to support manufacturing activities. The QE will be involved in preparing and implementing Installation/Operation/Performance qualification (IQOQPQ) plans, protocols and reports. The QE may also be involved in new product introduction (NPI) from concept through commercialization, through sustaining changes, as part of a cross-functional team. This includes active participation in origination of design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and applicable documentation. Develops, modifies, applies and maintains quality standards, and generates protocols and reports. The QE provides mentoring and coaching to Manufacturing, R&D and support personnel on Quality System Requirements and process improvement methodologies for the site's products and processes. ROLE AND RESPONSIBILITIES:

  • Direct and improve validation activities for the facility, including maintenance of the Validation Master Plan
  • Perform, evaluate and analyze validation protocols and associated data for compliance with site procedures and ISO guidelines
  • Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements
  • Actively partner with Manufacturing and supporting departments to create and revise qualification and validation protocols, studies, or other improvement projects
  • Participate in and support change control activities for documents and manufacturing processes
  • Investigate, analyze and correct process non-conformances (internal, external and systemic issues)
  • Actively seek, create and implement projects for quality improvement
  • Lead root cause analysis, implement corrective actions and ensure their effectiveness
  • Create, maintain and evaluate product/process trends
  • Collect, analyze, and present Quality data
  • Define, drive, and execute process and product improvement plans and ensure their effectiveness
  • Participate as internal auditor, and participate in external audits
  • Has a proactive and process-driven approach to problem solving
  • Able to define problems, collect data, establish facts, and draw valid conclusions
  • Other duties may be assigned, as required
    • BS in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or BS with other demonstrated equivalent work experience in the Quality Systems area pertaining to a scientific industry
    • Strong computer skills (MS Word, MS Excel, MS PowerPoint, Office365)
    • Knowledge of Quality Assurance and/or Quality Systems, including standards such as ISO 13485 Medical Devices - Quality Management System, ISO 9001 - Quality Management Systems, and ISO 14971 Medical Devices - Risk Management. PREFERRED SKILLS:
      • Knowledge of Operations and manufacturing processes
      • Familiar with enterprise software systems including Agile, TrackWise(r), SAP-LMS
      • Knowledge of statistical data analysis methods and tools (e.g. JMP, Minitab)
      • Able to motivate and positively influence peers
      • Able to resolve rapidly common or complex inquiries or complaints from internal and/or external customers and regulatory agencies
      • Able to effectively present information to groups of employees, site leadership, and customers
      • Able to read, analyze, and interpret common scientific data and QMS standards ADDITIONAL NOTES: No relocation is available for this position. At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission--enabling our customers to make the world healthier, cleaner and safer. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

        Department: Quality - provided by Dice Agile, Analysis, Biology, Biomedical, Data Analysis, Development, Excel, HTTP, ISO, Management, Mechanical, PowerPoint, Project, Protocols, Quality Assurance, Risk Management, SAP, Scientific, Validation

        Keywords: Thermo Fisher Scientific, Eugene , Quality Engineer - Validation, Change Control, Engineering , Eugene, Oregon

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