Quality Engineer

Company Name:
Please apply using the following link:https://careers-mtf.icims.com/jobs/1772/quality-engineer/job
The Quality Engineer supports the validations of a designated business unit, including the planning, writing and data analysis for validations. The QE uses technical writing skills,
statistics and other tools to implement products and processes to support
production and laboratories.
Job Duties:
1. Plan validation scope for product and process launches
2. Write protocols and reports demonstrating solid technical writing where background of projects and procedures are clearly presented and conclusions are definitively and clearly stated.
3. Perform data analysis that includes use of statistical tools, trending, ability to perform correlation analysis and other calculations as required.
4. Perform risk assessments independently and as a team applying techniques including FMEA and ALARP.
5. Coordinate with internal and external personnel for standards, data, testing, or other activities, as needed.
6. Perform other duties as assigned
Bachelor of Science in engineering or scientific field
Preferred: Bachelors Degree in Biomedical or Chemical Engineering; Masters Degree in Engineering or Science
3 years of validation experience in a regulated industry
Recommended: 3-5 years
Specific Licenses and/or Certifications:
Recommended: CQE
Specialized Knowledge, Skill, and Abilities :
Basic statistics (ANOVA, t-test), Fluent in Microsoft Office, specifically Word and Excel, Strong verbal and written communication skills
Preferred: Working knowledge of statistics including the use of statistical software (Excel, MiniTab); working knowledge of cell biology, microbiology or other biological science
Work Environment:
Physical Demands:
(if applicable)
Be able to lift 25 lbs infrequently, travel up to 20% of the time

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