Quality Engineer

Rhyz, Inc•Draper, UT

34d•Hybrid

About The Position

Wasatch Labs is seeking a Quality Engineer to perform quality control tests in the lab and on-site, assist with testing and calibrating lab equipment, and perform quality control tests on ingredients, completed products, and product samples. The role involves preparing samples for shipping, analyzing data, preparing reports for management, and performing risk assessment investigations. Key responsibilities include data review and analytics, leading root cause analyses for non-conformances, managing validation programs (cleaning, process, equipment qualification), providing oversight for the Environmental Monitoring program, executing CAPA and verifying effectiveness, conducting process risk assessments, and supporting quality systems by drafting and reviewing technical documents.

Requirements

Bachelor’s degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, Bioengineering, or a related technical STEM discipline.
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

2+ years’ laboratory experience in food manufacturing environment.
Experience in quality assurance, Good Lab Practices, and current Good Manufacturing Practice.
Willing to meet on-call obligations as needed.

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.