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Quality Engineer II

Company: Thermo Fisher Scientific
Location: Austin
Posted on: February 15, 2019

Job Description:

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.When you---re part of the team at Thermo Fisher Scientific, you---ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you---ll be supported in achieving your career goals.How will you make an impact?Provide Quality Assurance support to the Austin site. Help strengthen and improve our quality system. Help educate and promote adherence to Quality Assurance policies and requirements. The Quality Engineer will be responsible for driving the execution of quality goals and objectives. Position will proactively drive actions to meet internal and external customer expectations for quality. Position will work collaboratively with internal departments to identify and implement solutions to address quality/compliance issues. Creative in approach to meeting requirements with technical input.What will you do?

  • Provide guidance and direction to ensure ISO/Quality system compliance
  • Resolve nonconforming material investigations through coordination of efforts across operations
  • Monitor and analyze nonconformities to identify products or processes requiring quality improvements
  • Evaluate deviations, non-conformances, customer complaints and process/product change control for completeness and impact on products.
  • Manage customer complaints, including trending and problem solving
  • Manage problem records, complaint records, and corrective and preventive actions
  • Verify corrective and preventive action effectiveness
  • Obtain and verify supporting test results and issue product certificates
  • Ensure accuracy and regular updates of Quality documents
  • Assist with audits of the quality system
  • Participate, as needed, on new product teams.
  • Perform all job duties in a safe manner and obeys all safety policies and procedures
  • Perform all job duties consistent with the Code of Ethics and the 4-I values
  • Perform all job duties within ISO standards and regulatory requirements
  • Perform other duties and cross training as assignedHow will you get here?
  • EducationBachelor---s degree required in a scientific disciplineExperience
  • 5+ years of experience in a manufacturing or quality environment
  • Previous experience in an ISO 9001 or 13485 compliant manufacturing environment
  • Experience with FDA Medical Device or USDA regulations
  • Previous experience with SAP and Oracle Enterprise ERP systemsKnowledge, Skills, Abilities
  • Strong oral and written communication skills with a demonstrated ability to work in a cross functional team environment and to effectively interact with all levels in the company.
  • Effective communication skills and the ability to communicate with internal and external customers are essential.

    Keywords: Thermo Fisher Scientific, Austin , Quality Engineer II, Engineering , Austin, Texas

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