Quality Engineer

Nu Skin

Draper, UT

Estimated pay: Est. $19–$30/hr (market estimate, not employer-stated)

Shift: Full time

**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 to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to transport testing equipment or process samples.**
• **Activities: Balancing, reaching, standing, walking, feeling, talking, hearing, and repetitive motions required during cleanroom walkthroughs, floor audits, and validation execution.**
• **Visual Acuity: High visual acuity required for analyzing statistical datasets, reading technical schematics (P&IDs), inspecting fine component defects, and operating measurement instrumentation.**

Typical Environmental Conditions

• **Split between a standard** **administrative/office** **environment (data analysis, report drafting) and active** **manufacturing/laboratory** **spaces (cleanrooms, compounding rooms, and utility areas).**
• **Personal Protective Equipment (PPE) may be required depending on operational areas (e.g., cleanroom gowns, safety glas