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Quality Engineer - Eugene, OR #4953979


Company: Thermo Fisher Scientific

Date: 05/18/2018

Category: Internet Services

City: Eugene, OR

Job Description


ROLE AND RESPONSIBILITIES


  • Create and implement projects for quality improvement


  • Collect, analyze, and present Quality data


  • Actively partner with Manufacturing departments to provide Quality Assurance support


  • Investigate, analyze and correct non-conformances (internal, external and systemic issues)


  • Lead root cause analysis, implement/provide corrective actions and ensure their effectiveness


  • Create, maintain and evaluate product/process trends, designing and/or participating in process and product improvement plans


  • Ensure process risk assessment is complete in all the processes/products (i.e dFMEA, pFMEA)


  • Responsible to approve installation qualifications (IQs) engineering studies, operation qualification (OQs) and process qualification (PQs) when designated


  • Recommend product revisions, process changes, and testing procedures to assure that quality standards are being attained


  • Create quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality


  • Participate as internal auditor, and participate in external audits


  • Participates actively in Continuous Improvement programs


  • Participate in change control activities for documents and manufacturing processes


  • Participate in Product Development Process assuring design quality elements are maintained and compliant with ISO 13485 and applicable regulations (e.g., traceability matrix, design verification stages, process validation, quality control plan)


  • Laboratory experiments, as required


  • Other duties may be assigned, as required


  • Travel requirement: 0-10%

QUALIFICATIONS AND EDUCATION REQUIREMENTS


  • 1+ year experience in a Quality Engineering position – familiarity with and execution of principles within Certified Quality Engineer (ASQ CQE) Body of Knowledge


  • BS in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or demonstrated equivalent work experience in the Quality Engineering area pertaining to a scientific industry


  • Knowledge in standards such as ISO 13485:2003 Medical Devices – Quality Management System, ISO 14971:2007 Medical Devices – Risk Management, and ISO 9001:2008 – Quality Management Systems

PREFERRED SKILLS


  • Knowledge of Operations and manufacturing processes


  • Scientific laboratory experience highly desired


  • Familiarity with enterprise software systems including Agile, TrackWise®, SAP-LMS


  • Able to motivate and positively influence peers


  • Ability to read, analyze, and interpret common scientific and technical data and QMS standards


  • Ability to resolve rapidly common inquiries or complaints from internal and/or external customers and regulatory agencies


  • Ability to effectively present information to groups of employees, site leadership, and customers


  • Ability to define problems, collect data, establish facts, and draw valid conclusions

ADDITIONAL NOTES


No relocation is available for this position.


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.


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