Job Title: Quality Engineer (Mid-Level) – Medical, Cosmetic & OTC Manufacturing
Location: Las Vegas, NV
Department: Quality Assurance / Regulatory Compliance
Reports To: Director Regulatory/Quality
Type: Full-Time | [On-site]
Starting salary: $108,000/yr

POSITION SUMMARY:

We are seeking a proactive and detail-oriented Quality Engineer with experience in regulated industries to support our medical device, cosmetic, and OTC drug manufacturing operations. In this role, you will help maintain and improve our quality systems, ensure regulatory compliance, and drive continuous improvement across product lines.
This is an excellent opportunity for a quality professional ready to apply their expertise in FDA-regulated environments while supporting a fast-paced, contract manufacturing operation that partners with leading health and beauty brands.

QUALIFICATIONS:

• Bachelor’s degree in engineering, Life Sciences, or related technical field
• 3–5 years of quality experience in medical device, cosmetics, pharmaceutical, or OTC manufacturing
• Working knowledge of FDA regulations (21 CFR Parts 820, 210/211), ISO 13485, and ISO 22716
• Hands-on experience with CAPA, root cause tools (e.g., 5 Whys, Fishbone, 8D), and quality investigations
• Strong understanding of GMP, batch record review, and product release procedures
• Excellent written and verbal communication skills
• Strong organization and documentation skills in a regulated setting
• Proficiency with Microsoft Office; experience with electronic QMS a plus

PREFERRED QUALIFICATIONS:

• ASQ Certification (CQE, CQA, etc.)
• Experience with OTC monograph and 510(k) support
• Knowledge of cosmetic regulations
• Familiarity with Lean / Six Sigma tools
• Experience in a contract manufacturing or private label environment
  

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Job Type: Full-time
Pay: From $108,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor’s (Required)

Experience:

• Medical devices, cosmetics, pharmaceutical, or OTC : 5 years (Required)
• FDA regs 21 CFR Parts 820, 210/211, ISO 13485, ISO 22716: 3 years (Required)
• Hands-on w/CAPA, root cause tools 5 Whys Fishbone 8D,: 5 years (Required)
• GMP, batch record review, product release procedures: 3 years (Required)

Ability to Commute:

• Las Vegas, NV 89139 (Required)

Work Location: In perso

• Ensure compliance with applicable regulations and standards, including 21 CFR Part 820, Part 210/211, ISO 13485, and ISO 22716
• Support quality system elements including: CAPA, deviations, change control, risk management, document control, and training
• Support internal audits, as well as assist with FDA inspections, ISO audits, and customer audits
• Investigate nonconformances (NCs), perform root cause analysis, and implement corrective/preventive actions
• Review and approve change orders, specifications, SOPs, and validation protocols (IQ/OQ/PQ)
• Collaborate with cross-functional teams (R&D, Regulatory, Production) to support product development and transfers
• Assist in the qualification of raw materials, packaging components, equipment, and suppliers
• Analyze quality trends (complaints, deviations, NCs) and present findings to support decision-making
• Ensure product labeling, release testing, and documentation meet GMP and regulatory expectations
• Support stability programs and product quality reviews as needed