Quality Engineer (Test Method Validation)

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

Overview

• Ensures compliance with applicable standards and regulatory requirements (e.g., FDA, ISO)


• Leads laboratory-based quality activities, including hand on experience with Test Method Validation (TMV), Design Verification (DV), and product testing


• Authors, executes, and reviews test plans protocols, and reports to support product development


• Execute hands-on laboratory testing, data analysis, and technical investigations


• Collaborates with Design Engineering, Regulatory, and Laboratory staff to ensure testing activities are appropriately planned, executed, and documented


• Supports design controls, risk management, and other quality activities as needed

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

Requirements

• 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

Why Join Nemera?

At Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients’ lives.

POSITION RANGE

$95,000- $115,000USD Salaried (This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.)

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.

With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.

Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).

We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.