This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to or call me at +1(732)-276-1791

Role: Quality Validation Engineer

Location: Holdrege, NE

Duration: 24 Months on w2

Job Description:

Responsibilities:

• Develop, execute, and document validation protocols for manufacturing processes, equipment, and systems.
• Ensure compliance with quality standards, including 21 CFR 820 and ISO 13485, for medical device validation.
• Perform root cause analysis and failure investigations to resolve quality issues.
• Use statistical tools (e.g., Minitab) to analyze data and improve processes.
• Collaborate with cross-functional teams to ensure product quality and adherence to validation requirements.
• Maintain validation documentation and ensure readiness for audits.
• Contribute to process improvements and implement Six Sigma methodologies if applicable.

Requirements:

• Education: Bachelor's degree (preferably in Engineering).
• 3+ years in Quality Engineering and Validation, preferably in the medical device industry.
• Strong understanding of failure analysis, engineering tolerances, and test methods.
• Proficient in statistical analysis tools (e.g., Minitab) and MS Office (Word, Excel, Project).
• Familiarity with quality system regulations (21 CFR 820, ISO 13485).

Preferred Certifications:

• Six Sigma Certification or ASQ CQE.