Lab Quality Engineer

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

Now Hiring: Lab Quality Engineer

Location: Arden Hills, MN
Pay Rate: $64.50 per hour

Looking for a high-impact quality engineering opportunity in a regulated laboratory environment? Join a leading preclinical testing team and help ensure compliance, quality excellence, and inspection readiness across laboratory operations and supplier networks.

Job Duties

• 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

Education Requirements

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

Experience Requirements

• 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
• Quality assurance experience within medical device, pharmaceutical, biologics, or other regulated industries preferred
• Experience with GLP (21 CFR 58) strongly preferred

Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plan
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks Program
• Health Savings Account (HSA)
• AD&D Insurance

If you're a quality-focused professional with laboratory and regulatory compliance experience, this is an excellent opportunity to contribute to meaningful scientific work while expanding your expertise in a highly regulated environment.