Quality Engineer


Job ID 18-00012

Industry Professional Jobs

Job Type Permanent

Location Edison, NJ

Description

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.

Responsibilities:
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.
6. Coordinate Processing Environmental Qualifications for controlled and uncontrolled areas at Company.
7. Write & execute protocols for controlled temperature units (CTU) at Company.
8. Perform other duties as assigned

Specialized Knowledge, Skill, and Abilities:
Basic statistics (ANOVA, t-test), Fluent in Microsoft Office, specifically Word and Excel, Strong verbal and written communication skills

Work Environment:
Office Environment, Laboratory Environment and Occasional Clean Room Access
Physical Demands:
Be able to lift 25 lbs. infrequently, travel up to 50% of the time
Ability to gown in clean room environment



Qualifications

Education:
Bachelor's Degree in Biomedical or Chemical Engineering; Master's Degree in Engineering or Science

Experience:
3-5 years of validation experience in a regulated industry
Specific Licenses and/or Certifications:
CQE
Specialized Knowledge, Skill, and Abilities:
Working knowledge of statistics including the use of statistical software (Excel, MiniTab)
Working knowledge of cell biology, microbiology or other biological science