Regulated Lab Quality Engineer – ISO/GLP Compliance

Pro Staff; Arden Hills (MN); On-site; USD 73,000 - 104,000; Full time

Benefits offered by this job

Medical Insurance

401(k)

EAP

Commuter/Parking

People Perks Program

Health Savings Account

AD&D Insurance

Job summary

Pro Staff is hiring a Lab Quality Engineer in Arden Hills, MN, offering $64.50 per hour. The role focuses on quality systems in a regulated lab, ensuring compliance, inspection readiness, and supplier quality across operations and networks.

Responsibilities include conducting internal and supplier audits, reviewing data and records, supporting CAPA investigations, and preparing reports for management. Requires a Bachelor's in a scientific field and 3+ years of lab experience with ISO 17025/13485

Qualifications

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

Responsibilities

• Conduct internal and supplier quality audits for laboratory systems, processes, and testing activities.
• 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 audits

Regulatory compliance

Technical writing

Communication

Education

Bachelor's degree in Chemistry or Life Sciences

Job description

Pro Staff is hiring a Lab Quality Engineer in Arden Hills, MN, offering $64.50 per hour. The role focuses on quality systems in a regulated lab, ensuring compliance, inspection readiness, and supplier quality across operations and networks.

Responsibilities include conducting internal and supplier audits, reviewing data and records, supporting CAPA investigations, and preparing reports for management. Requires a Bachelor's in a scientific field and 3+ years of lab experience with ISO 17025/13485