Laboratory Compliance Specialist

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

Job 2979 - Laboratory Compliance Specialist - Contract located in Hennepin County, Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages. MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill‑set Engineering staff and SME’s (Subject Matter Experts). MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Applicants must be authorized to work in the U.S. in accordance with applicable law.

This position is not eligible for employer-sponsored work authorization now or in the future.

About The Role

Are you passionate about materials science and analytical chemistry? As a Laboratory Compliance Specialist, you will play a critical role in supporting our internal materials characterization laboratory by ensuring the integrity and compliance of data, documentation, and testing interpretations. While this is not a hands‑on laboratory position, it requires strong scientific judgment to partner with R&D engineers and scientists, enabling high-quality analytical and materials science testing. This role is essential in maintaining regulatory compliance and driving continuous improvement in documentation and laboratory practices.

Work Model

• At our Client's site, collaboration is key. This position follows an on‑site work model, requiring presence in our local office five days per week.

Key Responsibilities

• Conduct peer reviews of analytical test data and materials characterization results using both paper-based and electronic systems 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) based on review findings.
• 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 secondary documentation such as equipment logs, verification logs, and training records.
• Collect, analyze, and trend quality indicator data to support laboratory objectives and management reviews.
• Assist with transitions to new laboratory systems as required.

Required Qualifications

• Bachelors degree in chemistry, materials science/engineering, biology, biochemistry, or a related field-or equivalent relevant experience.
• Minimum of 3 years of experience in a laboratory scientist/engineer role or in peer/quality review or technical writing.
• Strong knowledge of good documentation practices and familiarity with ISO standards and/or quality systems.
• Proven experience in a regulated, audit‑facing environment.
• Proficiency in Microsoft Office Suite (Word, Excel, Teams, Outlook).

Preferred Qualifications

• Hands‑on experience interpreting materials science testing results, including metallography, microhardness testing, SEM/EDS, tensile testing, corrosion testing, and chemical analysis.
• Familiarity with PTFE material testing and characterization.
• Exceptional technical writing and communication skills.
• Proficiency in software tools such as Trios, Minitab, Empower, and OMNIC/OMNIC Paradigm.
• Knowledge of sample preparation and various mechanical and analytical testing methods.
• Ability to provide constructive feedback on documentation.

• Sponsorship is not available for this position

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.