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Quality Engineer, Supplier job in Edison

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MTF Biologics jobs
New Jersey (NJ), Edison
Job Code:  2018-3388
Employer:  MTF Biologics
Category:  Operations
Manufacturing Engineer
Manufacturing
Manufacturing
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, 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
Plan validation scope for product and process launches
Write protocols and reports demonstrating solid technical writing where background of projects and procedures are clearly presented and conclusions are definitively and clearly stated.
Perform data analysis that includes use of statistical tools, trending, ability to perform correlation analysis and other calculations as required.
Perform risk assessments independently and as a team applying techniques including FMEA and ALARP.
Coordinate with internal and external personnel for standards, data, testing.
Perform other duties as assigned
Supplier QE Responsibilities

Ensures that all component and supplier qualifications are performed in a timely manner to support business requirements.
Review supplier manufacturing processes and quality systems and conduct technical/quality system assessments, as require.
Technical liaison between MTF and external suppliers.
Work with suppliers to implement processes that meet MTF requirements.
Participate in all product transfer discussions and provide input from quality perspective for all project plans.

Qualifications
Education:

Bachelor of Science in engineering or scientific field

Experience:

3 years of validation experience in a regulated industry

Specific Licenses and/or Certifications:

 

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:

(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: (2018-3388)
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