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Danaher Corporation Quality Assurance Engineer in Bothell, Washington

Primary Responsibilities:

  • Support qualification and validation activities for equipment, facilities, production process and test methods. This includes writing or reviewing protocols, deviation investigations, and final reports. Also provide oversight of protocol execution, test result analysis,

  • Represent QA by collaborating on teams focusing on controls, process transfer, validation, monitoring and risk management.

  • Prepare complex data analysis for quality reports.

  • Support production related activities that include data evaluation and problem solving.

  • Support Quality System processes to ensure compliance to the Cepheid Quality Management System.

  • Review change controls, deviations, CAPAs and other documents and records for accuracy, completeness, and compliance.

  • Identify compliance gaps, write, or revise procedures, and implement processes to improve efficiency while ensuring compliance.

Requirements:

  • Bachelor’s degree in Chemical Engineering or a chemistry / life science discipline with 0 to 2 years of relevant work experience.

Knowledge and Skills:

  • Understanding of qualification and validation concepts.

  • Receives guidance to meet objectives and timelines.

  • Uses existing procedures to solves standard problems, works on assigned projects, and analyzes information to make judgements and obtain results.

  • Uses procedures and knowledge to recommend improvement.

  • Strong writing and communication skills and ability to work effectively in diverse matrix environment.

  • Strong skills in organization, accuracy, attention to detail and interpreting analytical data.

Preferred Qualifications/Experience:

  • Medical device manufacturing or quality experience.

  • Chemistry, biochemistry, or molecular diagnostics.

  • Electronic document management and/or equipment management systems.

Physical requirements/abilities:

  • Ability to work in an office environment.

  • Ability to be in laboratory environments.

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid

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