Lab Quality Engineer - QA, MS Data & Compliance

Novozen Healthcare LLC; Minnesota; On-site; USD 58,000 - 63,000; Full time

Job summary

Novozen Healthcare LLC is seeking a Laboratory Quality Engineer/Scientist in Minnesota. The role focuses on quality oversight of laboratory testing, data review, investigations, CAPA, audits, and compliance in a regulated medical device environment.

The ideal candidate has hands-on analytical/wet chemistry lab experience, 5+ years in lab/QA roles, and familiarity with ISO 17025, ISO 13485, and GLP requirements. Onsite work with strong data review skills is required.

Qualifications

• Bachelor’s degree in Chemistry, Life Sciences, or related field.
• 5+ years of relevant laboratory/quality experience.
• Hands-on analytical/wet chemistry laboratory experience.
• Laboratory Quality/QA experience.
• Experience in a regulated laboratory/testing environment.
• MS data experience is highly preferred.
• Knowledge of ISO 17025, ISO 13485, and/or 21 CFR Part 58 (GLP).
• Strong technical data review and problem-solving skills.
• Strong written and verbal communication.
• Comfortable working onsite in a laboratory environment.

Responsibilities

• Support laboratory quality and testing activities.
• Review analytical laboratory data and identify quality issues.
• Support investigations, CAPA, audits, and inspection readiness.
• Perform quality reviews and ensure laboratory compliance.
• Work closely with laboratory scientists and testing teams.
• Support continuous improvement of laboratory processes.

Skills

Analytical/wet chemistry

Quality/QA experience

Mass spectrometry data experience

Data review

Communication

Education

Bachelor's degree in Chemistry, Life Sciences, or related field

Tools

Mass Spectrometry data analysis tools

Quality management systems basics

Job description

Novozen Healthcare LLC is seeking a Laboratory Quality Engineer/Scientist in Minnesota. The role focuses on quality oversight of laboratory testing, data review, investigations, CAPA, audits, and compliance in a regulated medical device environment.

The ideal candidate has hands-on analytical/wet chemistry lab experience, 5+ years in lab/QA roles, and familiarity with ISO 17025, ISO 13485, and GLP requirements. Onsite work with strong data review skills is required.