Quality Validation Engineer

Nemera France SAS; Buffalo Grove (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in drug delivery devices is seeking a Quality Engineer to ensure product quality and compliance. The role involves managing validations, supplier quality evaluations, and leading continuous improvement projects. Ideal candidates will have a Bachelor's degree and experience in the Medical Device industry.

Qualifications

• At least 3 years of experience in a Quality role, preferably in the Medical Device industry.
• Experience in technical writing, IQ/OQ/PQ, and equipment validation is preferred.

Responsibilities

• Assist the Quality Manager in coordinating and executing objectives across departments.
• Manage the execution of validations and the creation of written protocols.
• Lead continuous improvement projects using Six Sigma methodologies.

Skills

Communication

Statistical Knowledge

Problem Solving

Education

Bachelor’s degree in Engineering, Science, or related field

Tools

Microsoft Office

SAP

Job description

Quality Engineer - Capital Equipment Validation

• Full-time
• Education Level: Bachelor's Degree
• Legal entity: Nemera Vernon Hills

Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.

The Quality Validation Engineer is responsible for planning, coordinating, and managing assigned projects to ensure that product development and production meet customer and internal quality standards. This includes leading investigations of customer complaints, working with Supply Chain management to evaluate and manage supplier performance, and collaborating with other staff to accomplish these duties.

Responsibilities:

• Assist the Quality Manager in coordinating and executing objectives across departments to maximize product quality and operational efficiency while minimizing costs.
• Identify and resolve system inefficiencies that increase quality costs.
• Manage the execution of validations and the creation of written protocols.
• Oversee change control activities.
• Assess customer complaint investigations and corrective actions for compliance with FDA, QSR, ISO, and customer requirements.
• Apply CAPA problem-solving techniques to reduce failures, using tools like FMEA, DOE, Cause and Effect, Flow Charts, SPC, and evaluate their effectiveness.
• Analyze statistical data to determine standards and propose quality improvements, including inspection methods and sampling plans.
• Evaluate compliance with specifications and standards based on relevant information and judgment.
• Develop and review product specifications for existing products.
• Plan and manage supplier quality evaluations, including scheduling and auditing suppliers.
• Interact with suppliers to ensure mutual understanding of requirements and support quality agreements.
• Organize and promote training related to quality activities, including statistics, DOE, GR&R, and sampling plans.
• Engage with customers to ensure mutual understanding of requirements and objectives.
• Assist during customer audits and lead resolution of findings.
• Maintain compliance with ISO and FDA QSR quality systems.
• Support ongoing quality policies, including regulatory and safety standards, and continuous improvement initiatives.
• Lead continuous improvement projects using Six Sigma methodologies.
• Perform other duties as assigned.

Preferred/Required Education/Skills:

• Bachelor’s degree in Engineering, Science, or related field.
• At least 3 years of experience in a Quality role, preferably in the Medical Device industry (ISO13485).
• Experience in technical writing, IQ/OQ/PQ, and equipment validation is preferred.
• Experience working onsite in manufacturing is strongly preferred.
• Excellent communication skills in English.
• Ability to apply advanced mathematical concepts and intermediate statistical knowledge (SPC).
• Six Sigma training or certification is preferred.
• Proficient in Microsoft Office; SAP experience is a plus.
• Ability to work independently and understand how individual roles contribute to the overall quality objectives.
• Work in a clean manufacturing environment, including moderate noise levels and PPE requirements.
• Physical ability to lift up to 30 lbs, perform repetitive movements, and stand, sit, or walk for up to 80% of a shift.
• Willingness to travel up to 25%, including international travel.

All your information will be kept confidential according to EEO guidelines. Nemera is an equal opportunity employer and complies with federal laws regarding employment eligibility in the United States.