Lab Quality Engineer

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

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.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

About Us

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors.