Lab Compliance & Quality Systems Lead

Medical Engineering Consultants (MEC); Minnesota; On-site; USD 85,000 - 110,000; Full time

Job summary

Medical Engineering Consultants (MEC) is seeking a Laboratory Compliance Specialist to support our internal materials characterization lab. You will ensure data integrity, documentation quality, and testing interpretations, partnering with R&D engineers to enable high-quality analytical work.

This is an on-site, contract‑based role requiring strong scientific judgment. The role emphasizes regulatory compliance, good documentation practices, and continuous improvement of lab practices and

Qualifications

• Bachelor''s degree in a relevant science or equivalent experience.
• At least 3 years in a lab scientist/engineer role or in peer/quality review.
• Strong knowledge of good documentation practices and ISO standards/quality systems.
• Proven experience in a regulated, audit-facing environment.
• Proficiency in Microsoft Office Suite (Word, Excel, Teams, Outlook).

Responsibilities

• Conduct peer reviews of analytical test data and materials characterization results with minimal supervision.
• Validate data intended for regulatory submissions to ensure accuracy and compliance.
• Recommend and implement process improvements to enhance laboratory efficiency and regulatory adherence.
• Lead initiatives to strengthen documentation practices and standards.
• Initiate or facilitate laboratory investigations (OOS/OOT, deviations, non-conformances).
• Author and revise methods, procedures, and work instructions; contribute to protocols, reports, SOPs, and technical documentation.
• Provide compliance oversight and support for special projects within or beyond the characterization lab.
• Review equipment logs, verification logs, and training records.
• Collect, analyze, and trend quality indicator data to support lab objectives and management reviews.
• Assist with transitions to new laboratory systems as required.

Education

Bachelor''s degree in chemistry, materials science/engineering, biology, biochemistry, or related field

Tools

Trios

Minitab

Empower

OMNIC Paradigm

Excel

Word

Outlook

Job description

Medical Engineering Consultants (MEC) is seeking a Laboratory Compliance Specialist to support our internal materials characterization lab. You will ensure data integrity, documentation quality, and testing interpretations, partnering with R&D engineers to enable high-quality analytical work.

This is an on-site, contract‑based role requiring strong scientific judgment. The role emphasizes regulatory compliance, good documentation practices, and continuous improvement of lab practices and