Quality Engineer

Rhyz•Draper, UT

33d•Hybrid

About The Position

Wasatch Labs is seeking a Quality Engineer to perform quality control tests, assist with equipment calibration, and analyze data. This role involves ensuring product integrity through rigorous testing and adherence to company policies. The Quality Engineer will also conduct risk assessments, lead investigations for non-conformances, manage validation programs, oversee environmental monitoring, and execute CAPA plans. Support for quality systems, including SOPs and technical reports, is also a key part of this position.

Requirements

Bachelor’s degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, Bioengineering, or a related technical STEM discipline.
2+ years’ laboratory experience in food manufacturing environment.
Experience in quality assurance, Good Lab Practices, and current Good Manufacturing Practice.
2–5 years of progressive Quality Engineering or Quality Control experience within an FDA-regulated manufacturing environment (Cosmetics, OTC, Pharmaceuticals, or Medical Devices).
Proven experience with root cause analysis (RCA) tools, CAPA systems, and statistical process control (SPC).
Direct experience developing and executing Cleaning Validation protocols and managing Environmental Monitoring programs.
Strong working knowledge of cGMP, ISO standards (e.g., ISO 22716 / ISO 13485), and GLP guidelines.
Capable of prioritizing tasks to meet goals and ensure product quality.
Ability to communicate effectively.

Nice To Haves

Experience in quality assurance, Good Lab Practices, and current Good Manufacturing Practice.

Responsibilities

Perform quality control tests in the lab as well as on-site when necessary.
Assist with testing and calibrating lab equipment in preparation for specific tasks.
Perform quality control tests on ingredients, completed products and product samples.
Prepare samples prior to shipping them to customers.
Follow all company policies and procedures to ensure product integrity and quality control.
Analyze retrieved data and prepare reports for laboratory management.
Perform risk assessment investigations as needed based on trending data.
Perform statistical review and trend analysis on manufacturing, testing, and process data to proactively identify process variability, operational gaps, and potential quality risks.
Lead cross-functional root cause analyses (using methodologies such as 5-Why, Fishbone, FMEA) for bulk, raw material, and out-of-specification (OOS)/out-of-trend (OOT) investigations; evaluate and document technical rationales.
Plan, execute, and document cleaning validation, process validation, and equipment qualification protocols (IQ/OQ/PQ) to ensure operational compliance and sanitary control.
Provide engineering and technical oversight for the site Environmental Monitoring program, evaluating environmental controls, airflow/cleanroom integrity, and utility systems (e.g., purified water systems).
Design targeted CAPAs to address identified process gaps and design verification protocols to measure the long-term effectiveness of implementation.
Conduct formal quality risk assessments (QRA) on operational changes, new raw material implementations, and process modifications to maintain product safety and compliance.
Draft, revise, and review technical SOPs, validation protocols, control charts, and technical reports for site leadership and regulatory audits.