Quality Engineer - TMV, DV & Regulated Lab Testing

Socket.dev; Chicago (IL); On-site; USD 95,000 - 115,000; Full time

Job summary

Nemera, a leading developer of drug-delivery devices, seeks a quality professional in the United States (Chicago area) to ensure compliance with FDA/ISO standards. You will perform hands-on lab testing, develop TMV and DV plans, and collaborate with Design Engineering, Regulatory, and Laboratory staff to plan, execute, and document testing activities.

You will author and review protocols, analyze data, investigate deviations, and contribute to design controls and risk management.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Science or related field.
• 2-4 years of experience in QC, laboratory, or quality departments within medical device or pharmaceutical industries.
• Working knowledge of relevant regulations and industry standards (FDA 21 CFR 820, ISO 13485, etc.).
• Proven experience authoring and executing TMV and DV documentation.
• Strong hands-on laboratory testing and data analysis experience.
• Strong technical writing and documentation skills.
• Experience with statistical analysis tools such as Minitab, JMP, or equivalent.
• Self-motivated with good communication and organization skills.

Responsibilities

• Author, review, and execute TMV protocols and reports
• Develop and execute Design Verification plans, protocols, and reports
• Support hands-on verification and validation testing activities
• Analyze test data, document results, and communicate findings to project teams
• Investigate test failures, deviations, and nonconformances; support root cause analysis and corrective actions
• Ensure accuracy, completeness, and traceability of testing and validation documentation
• Review and approve quality and testing documentation in accordance with development procedures
• Support project teams and laboratory on quality-related activities
• Provide support for other quality activities, including design controls and risk management documentation

Skills

Quality systems

Lab testing

Data analysis

Technical writing

Education

Bachelor’s or Master’s in Engineering/Science

Tools

Minitab

JMP

Job description

Nemera, a leading developer of drug-delivery devices, seeks a quality professional in the United States (Chicago area) to ensure compliance with FDA/ISO standards. You will perform hands-on lab testing, develop TMV and DV plans, and collaborate with Design Engineering, Regulatory, and Laboratory staff to plan, execute, and document testing activities.

You will author and review protocols, analyze data, investigate deviations, and contribute to design controls and risk management.