Lab Quality Engineer — Regulated QC, Audits & CAPA

Advantage Technical; Arden Hills (MN); On-site; USD 83,000 - 96,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Pet Insurance

401(k) Retirement Savings Plan

EAP

Job summary

Advantage Technical is seeking a Lab Quality Engineer in Arden Hills, MN to help ensure compliance and quality excellence across laboratory operations and supplier networks. The role focuses on audits, CAPA, and regulatory readiness in a preclinical setting.

You will review data, procedures, and records, support vendor quality activities, and collaborate with cross-functional teams to improve quality systems in a highly regulated environment.

Qualifications

• Bachelor's degree in Chemistry, Life Sciences, or a related scientific field.
• Minimum 3 years of experience in a technical or laboratory environment.
• Experience with ISO/IEC 17025, ISO 13485, and/or 21 CFR 58.
• GLP (21 CFR 58) experience preferred.

Responsibilities

• Conduct internal and supplier quality audits for laboratory systems, processes, and testing activities.
• Support compliance with ISO 13485, ISO/IEC 17025, 21 CFR 58 (GLP), and related regulatory requirements.
• Review laboratory operations, study data, procedures, and quality records for accuracy and compliance.
• Assist with vendor qualification, vendor audits, and supplier quality activities.
• Support CAPA investigations, corrective actions, and continuous improvement initiatives.
• Prepare audit reports and communicate findings to technical teams and management.
• Track audit responses and ensure timely resolution of quality issues.
• Support laboratories during regulatory, accreditation, and customer inspections.
• Collaborate with cross-functional teams to improve quality systems and processes.

Skills

Quality assurance

Technical writing

Communication

Regulatory knowledge

Education

Bachelor's degree

Job description

Advantage Technical is seeking a Lab Quality Engineer in Arden Hills, MN to help ensure compliance and quality excellence across laboratory operations and supplier networks. The role focuses on audits, CAPA, and regulatory readiness in a preclinical setting.

You will review data, procedures, and records, support vendor quality activities, and collaborate with cross-functional teams to improve quality systems in a highly regulated environment.