Analytical Lab Quality Engineer

Intellectt INC; Indiana (PA); On-site; USD 85,000 - 110,000; Full time

Job summary

Intellectt INC in Minnesota is seeking an Analytical Process Characterization Lab Engineer with 5+ years' experience to support laboratory quality and analytical testing in a regulated medical device environment.

You will provide quality oversight for laboratory testing, review data, support investigations, CAPAs, and readiness for inspections, collaborating with onsite laboratory teams to ensure compliance.

Qualifications

• Minimum 5+ years of relevant laboratoy/quality experience.
• Hands-on analytical/wet chemistry laboratory experience.
• Laboratory Quality/QA experience in a regulated environment.
• Knowledge of ISO/IEC 17025, ISO 13485, and/or 21 CFR 58 (GLP).
• Mass Spectrometry (MS) data experience preferred/key differentiator.

Responsibilities

• Provide quality oversight for laboratory testing and operations.
• Review analytical data and identify quality issues.
• Support investigations, CAPAs, and inspection readiness.
• Work with laboratory teams on quality and compliance activities.

Skills

5+ years experience

Analytical/wet chemistry

Laboratory QA in regulated env

Strong communication onsite

MS data experience

Education

Bachelor's degree in Chemistry or Life Sciences

Job description

Job Title: Analytical Process Characterization Lab Engineer

Location: Minnesota Onsite

Employment Type: W2

Duration: Long term

Job Summary

We are seeking an Analytical Process Characterization Lab Engineer with a minimum of 5+ years of relevant experience to support laboratory quality and analytical testing activities in a regulated medical device environment.

Key Responsibilities

• Provide quality oversight for laboratory testing and operations.
• Review analytical data and identify quality issues.
• Support investigations, audits, CAPAs, and inspection readiness.
• Work with laboratory teams on quality and compliance activities.

Requirements

• 5+ years of relevant laboratory/quality experience.
• Hands-on analytical/wet chemistry laboratory experience.
• Laboratory Quality/QA experience in a regulated environment.
• Bachelor's degree in Chemistry or related Life Sciences.
• Knowledge of ISO/IEC 17025, ISO 13485, and/or 21 CFR 58 (GLP).
• Experience reviewing laboratory data and supporting investigations.
• Mass Spectrometry (MS) data experience preferred/key differentiator.
• Strong communication skills and ability to work onsite.