Quality Engineer

Company:

Wasatch Labs Duties and Responsibilities Essential 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.

Data Review & Analytics:
Perform statistical review and trend analysis on manufacturing, testing, and process data to proactively identify process variability, operational gaps, and potential quality risks.

Non-Conformance & Root Cause Investigations:
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.

Validation Program Management:
Plan, execute, and document cleaning validation, process validation, and equipment qualification protocols (IQ/OQ/PQ) to ensure operational compliance and sanitary control.

Environmental Monitoring (EM) Oversight:
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).CAPA Execution & Effectiveness Verification:
Design targeted CAPAs to address identified process gaps and design verification protocols to measure the long-term effectiveness of implementation.

Process Risk Assessments:
Conduct formal quality risk assessments (QRA) on operational changes, new raw material implementations, and process modifications to maintain product safety and compliance.

Quality Systems Support:
Draft, revise, and review technical SOPs, validation protocols, control charts, and technical reports for site leadership and regulatory audits.

Qualifications/Knowledge, Skills, & Abilities Requirements

Education:

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. (Preferred)

Experience:

2–5 years of progressive Quality Engineering or Quality Control experience within an FDA-regulated manufacturing environment (Cosmetics, OTC, Pharmaceuticals, or Medical Devices).Technical

Skills:

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.

Willing to meet on-call obligations as needed.

Ability to communicate effectively.

Machines Typically Operated
· Computer operations, word processing, spreadsheet, comprehensive statistical package, etc., pH meter, Scale, Analytical Scale, Hardy Diagnostics Compact Dry Micro Plating, Instrument Calibration, and Soleris microbiology system.
· Enterprise software systems (QMS, LIMS, ERP, Data Historians).
· Statistical analysis packages (Minitab, JMP, Advanced Excel).
· Analytical laboratory and process monitoring equipment (pH meters, analytical balances, water sampling tools, air samplers, calibration standards).Typical

Physical Requirements
· Work Intensity:
Light work—exerting up…