Quality Engineer Job in New Jersey (NJ), Medical Device, Medical Device Career, Full Time Jobs in MTF Biologics
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Quality Engineer job in Edison

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MTF Biologics jobs
New Jersey (NJ), Edison
Job Code:  2018-3502
Employer:  MTF Biologics
Category:  Medical Device
Medical Device
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  Edison
Zip Code:  08837
Map: 
Edison, NJ 08837, USA (Show on map)
09/10/2018

Description

Overview/Risks
The Quality Engineer supports the validations of a designated business unit or specialty, 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. Perform other duties as assigned

Qualifications
MINIMUM JOB REQUIREMENTS

Education:

Bachelor of Science in engineering or scientific field

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

Experience:

3 years of validation experience in a regulated industry; preferably 3-5 years of validation experience in a regulated industry

Specific Licenses and/or Certifications:

Preferred-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:

Office Environment, Laboratory Environment and Occasional Clean Room Access

Physical Demands:

(if applicable)

Be able to lift 25 lbs infrequently, travel up to 20% of the time
Ability to gown in clean room environment
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Equal Employment Employer – Vet/Disability

ref: (2018-3502)
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