Quality Engineer I

Rockline Industries, people who make it right•Morristown, TN

13d•Onsite

About The Position

Iatric Manufacturing Solutions produces FDA-regulated wet wipes in controlled manufacturing environments where temperature and humidity are carefully managed to minimize environmental influences on our products and ensure comfortable working conditions for our team. As a Quality Engineer I, you will facilitate and maintain validation project documentation, including the Site Validation Master Plan. You will collaborate with customers on equipment and process validations, serve as a database administrator for Infinity QS (Statistical Process Control) software, and provide statistical analysis support for manufacturing, new product development, trials, and validations. You will also develop SOPs related to validation and risk management, monitor and prepare Key Performance Indicators (KPIs) for major customers, lead Corrective Action/Preventative Action (CAPA) activities and facilitate root cause investigations, train associates on quality topics such as SPC and CAPA, and drive continuous improvement initiatives with internal teams and external partners.

Requirements

Bachelor’s degree in Engineering, Science, or related field.
3+ years of engineering experience, preferably in manufacturing.
Background in nutritional products, medical devices, pharmaceuticals, or similar industries.
Experience in FDA-regulated environments.
Experience with validations.
Strong problem-solving and root cause analysis capabilities.
Ability to work independently and collaboratively in a fast-paced setting.

Nice To Haves

Flexible schedule to support production and validation activities.

Responsibilities

Facilitate and maintain validation project documentation, including the Site Validation Master Plan.
Collaborate with customers on equipment and process validations.
Serve as a database administrator for Infinity QS (Statistical Process Control) software.
Provide statistical analysis support for manufacturing, new product development, trials, and validations.
Develop SOPs related to validation and risk management.
Monitor and prepare Key Performance Indicators (KPIs) for major customers.
Lead Corrective Action/Preventative Action (CAPA) activities and facilitate root cause investigations.
Train associates on quality topics such as SPC and CAPA.
Drive continuous improvement initiatives with internal teams and external partners.