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 RD 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 qualitycompliance issues. Creative in approach to meeting requirements with technical input. What will you do? Provide guidance and direction to ensure ISOQuality 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 processproduct 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 assigned How will you get here? Education Bachelor's degree required in a scientific discipline Experience 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 systems Knowledge, 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. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here pageshoweeo-affirmative-action-statementaccessibility for further assistance. Thermo Fisher Scientific is an EEOAffirmative 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 Engineering
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