Lab Quality Engineer

Advantage Technical; Arden Hills (MN); On-site; USD 39,000 - 65,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401(k)

EAP

Commuter/Parking

People Perks

HSA

AD&D Insurance

Job summary

Advantage Technical in Arden Hills, MN is seeking a Lab Quality Engineer to support quality systems and regulatory compliance in a highly regulated laboratory environment.

The role focuses on ISO 13485, ISO/IEC 17025, and 21 CFR 58 (GLP), with responsibilities spanning audits, CAPA, supplier oversight, and documentation to ensure inspection readiness and continuous improvement.

Qualifications

• Bachelor's degree required in chemistry, life sciences, or related field.
• At least 3 years in a technical, laboratory, or quality-focused role.
• Strong knowledge of ISO 13485, ISO/IEC 17025, 21 CFR 58 (GLP) and related standards.
• Excellent written and verbal communication skills.
• Quality experience in medical device, pharmaceutical, biologics, or regulated industries preferred.

Responsibilities

• Support laboratory compliance with quality standards, regulations, and internal procedures.
• Conduct internal, external, and supplier quality audits.
• Evaluate laboratory systems, processes, and study data for accuracy and regulatory compliance.
• Review quality trends and support continuous improvement initiatives.
• Assist with CAPA activities and follow-up actions.
• Prepare and publish audit reports and communicate findings to stakeholders.
• Support vendor qualification and ongoing supplier oversight.
• Help laboratories prepare for inspections, audits, and accreditation reviews.
• Maintain quality records, documentation, and audit tracking systems.

Skills

Auditing

Regulatory knowledge

Documentation

Quality improvement

Education

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

Job description

Now Hiring: Lab Quality Engineer

Location: Arden Hills, MN
Pay Rate: Up to $47.00/hour

Are you an experienced Quality Engineer with a background in laboratory, medical device, pharmaceutical, or regulated environments? This is an excellent opportunity to join a leading preclinical laboratory team and play a key role in quality assurance, regulatory compliance, and continuous improvement initiatives.

Job Duties

• Support laboratory compliance with quality standards, regulations, and internal procedures.
• Conduct internal, external, and supplier quality audits.
• Evaluate laboratory systems, processes, and study data to ensure accuracy and regulatory compliance.
• Review quality trends and support continuous improvement initiatives.
• Assist with corrective and preventive action (CAPA) activities and follow-up actions.
• Prepare and publish audit reports and communicate findings to stakeholders.
• Support vendor qualification activities and ongoing supplier oversight.
• Help laboratories prepare for inspections, audits, and accreditation reviews.
• Maintain quality records, documentation, and audit tracking systems.

Qualifications

• Bachelor's degree in Chemistry, Life Sciences, or a related scientific field.
• Minimum 3 years of experience in a technical, laboratory, or quality-focused role.
• Strong knowledge of ISO 13485, ISO/IEC 17025, 21 CFR 58 (GLP), and related regulatory standards.
• Excellent written and verbal communication skills.
• Quality experience within medical device, pharmaceutical, biologics, or other regulated industries 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

This is a great opportunity to expand your quality engineering experience while supporting critical laboratory operations 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.

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.