Quality Engineer

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Job Title: Quality Engineer

Location: Morristown TN Onsite

Job Description:

ESSENTIAL ACCOUNTABILITIES:

Facilitate and maintain validation project documentation including the Site Validation Master Plan.

Serve as the database administrator for Infinity QS (Statistical Process Control) software.

Provide statistical analysis support for manufacturing new product development (NPD) trials and validation activities.

Develop SOPs relating to validation and risk management.

Monitor and prepare Key Performance Indicators (KPIs) for major customers.

Conduct quality/engineering studies to support manufacturing operations.

Facility Corrective Action / Preventive Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problemsolving techniques within the manufacturing plant.

Facilitate and train associates on quality topics required for their positions (SPC / CAPA).

Coordinate continuous improvement initiatives alongside internal and external (customer or supplier) representatives.

Demonstrate commitment to the companys RRITE Values of Renew Respect Integrity Teamwork and Excellence.

Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associates essential accountabilities.

Contribute to a cooperative working effort by demonstrating a willingness to perform other jobrelated work as needed or requested.

QUALIFICATION REQUIREMENTS:

(To perform this job successfully an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.)

Bachelors degree in engineering science or related field is required.

Three years of engineering experience preferably in a manufacturing environment is required.

Experience in an FDAregulated environment preferred.

Strong selfstarter with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a crossfunctional setting.

Demonstrated ability to perform technical NonConformance Investigations and Root Cause Analyses.

Ability to prioritize and handle multiple tasks; ability to meet deadlines in a fastpaced work environment.

Ability to have a flexible work schedule to support department projects and coordinate with production and validation schedules.

Technical background in nutritional products laboratory diagnostics medical devices pharmaceutical or similar industry.

Must Have: