Quality Engineer - TN

Quality Engineer - TN
Morristown, TN
Must be a US Citizen or Green Card holder.
This position develops and executes validation protocols (IQ / OQ / PQ)
as required for equipment, sanitization/cleaning, facilities, software,
and processes. This job will also work with customers regarding
customer-specific equipment and process validations.
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 problem-solving 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 job-related 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 FDA-regulated environment preferred.
Strong self-starter with the ability to work independently as well as
collaboratively in a team setting with peers and colleagues in a
cross-functional setting.
Demonstrated ability to perform technical Non-Conformance
Investigations and Root Cause Analyses.
Ability to prioritize and handle multiple tasks; ability to meet
deadlines in a fast-paced 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.
Required Knowledge, Skills, and Abilities: (Hiring Companies ATS Questions):
1. Do you have a Bachelors degree in engineering, science or related
field is required.
2. Do you have Three+ years of engineering experience, preferably in a
manufacturing environment is required.
3. Do you have experience in an FDA-regulated environment preferred.
4. Do you have demonstrated ability to perform technical Non-Conformance
Investigations and Root Cause Analyses.
5. Do you have technical background in nutritional products, laboratory
diagnostics, medical devices, pharmaceutical or similar industry.
6. Do you have Process Validation Experience
7. Must be a US Citizen or Green Card holder.