Quality Engineer - Medical Device Manufacturer | Itasca, IL - JN-072026-7062191

Tight-knit, small company culture
Opportunity to have direct access to C-Suite leadership

About Our Client

Our client is an electro-mechanical manufacturer of lighting fixtures and assemblies for medical device applications. They work with well-established, Fortune 500 organizations and are ISO 13485 certified and have an FDA-regulated facility. They offer a small company culture with a total of about 30 employees.

Job Description

Support the migration, testing, and validation of documentation within the electronic Quality Management System (eQMS).
Serve as an eQMS administrator, managing document control, training records, system administration, and related functions.
Oversee the Document Change Request (DCR) and Engineering Change Order (ECO) processes while ensuring proper document control and record retention.
Coordinate employee training programs by identifying development needs, creating training plans, and maintaining accurate training records.
Conduct internal quality audits and provide support during notified body, customer, and regulatory audits.
Lead product and process failure investigations, perform root cause analysis, monitor trends, and support Corrective and Preventive Action (CAPA) initiatives.
Perform incoming, in-process, and final inspections, while investigating product non-conformances and quality issues.
Review and approve production routers and documentation to support product release and manufacturing activities.
Partner with production teams to address and resolve non-conformances identified during manufacturing.
Facilitate Material Review Board (MRB) meetings, manage Non-Conformance Reports (NCRs), and collaborate with Purchasing on supplier quality issues and Supplier Corrective Action Requests (SCARs).
Gather, analyze, and review scrap data while working with management to determine appropriate material disposition.
Administer the calibration program by tracking inspection and test equipment, coordinating vendor services, and managing calibration schedules.
Maintain test records, preventive maintenance documentation, and environmental monitoring records to ensure compliance and traceability.
Apply extensive knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements to maintain regulatory compliance and drive continuous improvement of the Quality Management System.
Support regulatory affairs activities, including product registrations, adverse event reporting, UDI implementation, and compliance with evolving regulatory requirements.
Collect, analyze, and present quality and operational data to support projects, decision-making, and management reviews.
Perform additional quality, regulatory, and continuous improvement projects as assigned by the Head of Quality and Regulatory Affairs.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

High school diploma, associate degree, or equivalent required; a Bachelor's degree in Science, Engineering, or a related field is preferred.
Minimum of 4 years of experience, preferably within a manufacturing environment operating under ISO 13485 standards.
Strong written and verbal communication skills in English; Spanish language proficiency is a plus.
Excellent organizational and documentation skills with strong attention to detail and the ability to manage multiple tasks and records effectively.
Proficient in Microsoft Word, Excel, and Outlook; experience with ERP systems and Adobe applications is preferred.
Hands-on experience with electronic Quality Management Systems (eQMS), such as MasterControl, Greenlight Guru, or similar platforms, is required.
Working knowledge of ISO 13485 requirements and FDA regulations governing medical devices.
Proven ability to collaborate effectively with cross-functional teams across operations, engineering, quality, and regulatory functions.
Demonstrated success in identifying opportunities for and driving continuous process improvement initiatives.
Ability to read and interpret technical drawings and utilize precision measuring instruments for inspection and calibration activities.
Flexible and willing to work evenings and weekends as business needs require.
Experience supporting Class I and Class II medical device manufacturing is highly preferred.
Prior involvement with ISO and FDA audits, including preparation, participation, and follow-up activities, is strongly preferred.
Sponsorship not provided