Quality Systems Engineer

Job Title: Quality Systems Engineer

Job Description

The Quality Systems Engineer plays a crucial role in supporting the Quality Department by ensuring compliance of the Quality Management System (QMS) with applicable medical device standards and regulations. This position is essential for maintaining compliance with company operations, quality systems regulations, standards, good business practices, and documented procedures.

Responsibilities

• Ensure compliance with QMS through management of document control and authoring/updating Standard Operating Procedures (SOP).

• Maintain Corrective and Preventive Action (CAPA) activities, manage the CAPA system, and handle nonconformities and related quality investigation documents.

• Prepare and collect data for Management Review and Monthly Meetings.

• Support addressing complaints and reportability decision assessments.

• Support and/or lead third-party audits, including follow-up on actions.

• Partner with process owners to generate metrics reflecting the health of different Quality System elements.

• Organize and manage the Internal Audit program, including participation, leading audits, and ensuring effective closure of findings.

• Report Key Performance Indicators (KPI) to prevent nonconformities related to products, processes, or systems.

• Maintain the Quality Manual and Quality Procedures, ensuring they are appropriate for the business.

• Lead regulatory training and manage the training matrix and documentation system in compliance with QMS requirements.

• Maintain supplier approved list and supplier certification as per applicable regulations.

Essential Skills

• Bachelor's degree required.

• Quality Assurance/Quality Systems experience in an FDA-regulated industry, such as medical device or pharmaceutical.

• Knowledge and application of QSR/GMP/GCP regulations related to medical device manufacturing.

• Practical application of 21 CFR Part 820, 21 CFR Part 803, and familiarity with Device Master Record (DMR) requirements and design controls.

• Experience managing QMS software.

Additional Skills & Qualifications

• Blow-Fill-Seal experience is desired but not required.

• Calibration and internal/external audit experience is desired but not required.

Job Type & Location

This is a Permanent position based out of Mundelein, IL.

Pay and Benefits

The pay range for this position is $80000.00 - $90000.00/yr.

Will be on clients full benefits / PTO plan

Workplace Type

This is a fully onsite position in Mundelein,IL.

Application Deadline

This position is anticipated to close on Jan 19, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.