Quality Engineer

Katalyst Healthcares and Life Sciences

Chicago, IL

Job Summary:

Quality Engineer / Quality Compliance Engineer with experience supporting remediation efforts and maintaining quality standards within regulated medical device, pharmaceutical, OTC drug, and cosmetic environments.
Responsible for supporting Quality Management Systems (QMS), Design Controls, CAPA, Risk Management, supplier quality activities, process validation, and regulatory compliance while ensuring adherence to FDA and ISO quality standards.

Roles & Responsibilities:

Provide quality engineering support for Product Development, QMS, Design Controls, Design History Files (DHF), CAPA, Risk Management, and CE Technical File activities.
Support remediation projects and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable domestic/international regulations.
Collaborate with supplier representatives to resolve quality issues, implement CAPA/SCAR activities, and support supplier qualification and vendor management programs.
Lead investigations related to product/process non-conformances, deviations, and out-of-specification (OOS) results, performing root cause analysis and corrective actions.
Review design and quality documentation to ensure compliance with regulatory requirements and company standards.
Support process control, process validation, testing, inspection, and continuous improvement activities to enhance product quality and manufacturing efficiency.
Apply Statistical Process Control (SPC) methods and statistical analysis techniques to evaluate process performance and identify process variation trends.
Design and execute product testing, data analysis, and failure investigations to minimize defects and improve product reliability.
Coordinate product testing activities with internal teams and external laboratories.
Develop and maintain Device Master Records (DMR), product specifications, validation documentation, and technical files in compliance with regulatory requirements.
Support preparation of regulatory submissions including 510(k) documentation, letters to file, and other quality compliance documentation.
Collaborate with cross-functional teams including Manufacturing, Regulatory Affairs, Quality Systems, and Suppliers to ensure quality-compliant project execution.

Education & Experience:

Bachelor's degree in engineering, Science, Mathematics, or a related technical field.
2-5 years of Quality Engineering experience in Medical Device and/or pharmaceutical industries.
Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and regulated quality system requirements.
Hands-on experience with Device History Files (DHF), CAPA, Risk Management, supplier quality, and compliance activities.
Experience supporting investigations, process validation, remediation projects, and quality system compliance in regulated environments.
Knowledge of Design Controls, SPC, statistical analysis, process improvement methodologies, and validation activities.
Strong analytical, problem-solving, communication, and documentation skills.

Apply

Vacancy posted 20 hours ago

Similar jobs that could be interesting for youBased on the Quality Engineer in Chicago, IL vacancy

Quality Assurance Engineer
$100k - $120k
...Quality Assurance Engineer Employment type: Full time Worksite flexibility: Remote Who We Are CAI is a global services firm with over 9,000 associates worldwide and a yearly revenue of $1.3 billion+. We have over 40 years of excellence in uniting talent and...
Suggested
Full time
Contract work
Apprenticeship
Casual work
Local area
Remote work
Worldwide
Cai
Chicago, IL
4 days ago
Quality Assurance Engineer (Manual)
...cases fully exercise every aspect of the solution Execute smoke/regression testing for each release Support and consult with other engineering departments to support their build and QA processes Requirements 1–5 years of hands‑on QA manual testing experience in a client...
Suggested
Summer work
Casual work
Remote work
Home office
Flexible hours
Root16, LLC
Chicago, IL
4 days ago
QA Test Engineer (Banking Domain)
...Job Summary We are seeking an experienced Manual QA Test Engineer with strong banking domain experience to support end-to-end... ...Experience with MySQL Knowledge of Data Protection and Quality Assurance standards Prior experience with BMO or similar...
Suggested
Local area
Prophecy Technologies
Chicago, IL
4 days ago
Quality Assurance Engineer I
...MPC Products Corporation (Woodward MPC, Inc.) is seeking Quality Engineers to ensure adherence to quality standards through inspections and documentation. This role involves collaboration across departments to achieve product excellence. The successful candidates will...
Suggested
MPC Products Corporation
Niles, IL
3 days ago
Quality Assurance Engineer
...Job Role: Senior Quality Engineer (SDET) with Mainframes Location: Remote Log Time Contractor Required Skills: 8+ years of experience in mainframe testing with hands-on expertise 4+ years of experience in automation testing Strong proficiency in Java development...
Suggested
For contractors
Remote work
HR Pundits
Chicago, IL
2 days ago
Software Test Engineer
$80k - $90k
...to invest themselves in the outcomes. Position: Software Test Engineer Location: Colorado Springs, CO Remote Status: On-Site Job Id: 1... ...working collaboratively with the team to ensure on-time delivery of quality deliverables. Work closely with systems engineers, software...
Contract work
Work experience placement
Remote work
Flexible hours
Auria
Chicago, IL
1 day ago
Remote Cypress QA Engineer - API & SQL Validation
...A leading revenue management software firm is seeking a remote Quality Gatekeeper to design and maintain a scalable automation framework using Cypress.io and JavaScript. The role involves API testing, CI/CD integration, and collaboration with development teams. Candidates...
Remote work
PriceLabs
Chicago, IL
20 hours ago
Senior Quality Assurance Engineer
...design and implement functional and non-functional tests and quality practices driving application quality. Provide guidance and support... ...suites and processes through the use of new technologies and engineered solutions. Assist with projects as required contributing to...
Full time
Contract work
For contractors
Work at office
Local area
Sherwin-Williams
Chicago, IL
1 day ago
Senior QA Engineering
...Senior QA Engineer Chicago, IL – hybrid WFH (3 days remote, 2 days onsite) Summary This position is responsible for guiding and... ...managers and developers. This role is responsible for leading quality review of custom developed applications, including creation of...
Remote work
Work from home
1872 Consulting
Chicago, IL
2 days ago
QA Engineer
...QA Engineer As a QA Engineer you are responsible for quality delivery of products supporting our digital vision. You bring new ideas and modern delivery mindset and able to implementing it in development of the product. You will act as testing expert and are caught...
Software Technology Inc
Chicago, IL
4 days ago
Software Test Engineer
...Description: As a Software Test Engineer, you will contribute to quality assurance of software systems and/or applications. Responsibilities: Responsibilities of the incumbents are to provide manual and/or automation testing of features and...
Flexible hours
Kaav Inc.
Chicago, IL
3 days ago
Software Test Engineer
About Us Innovation. Sustainability. Productivity. This is how we are Breaking New Ground in our mission to sustainably advance the noble work of farmers and builders everywhere. With a growing global population and increased demands on resources, our products are...
CNH Industrial
Oak Brook, IL
5 days ago
Software Test Engineer
...Software Test Engineer As a Software Test Engineer, you will contribute to quality assurance of software systems and/or applications. Responsibilities of the incumbents are to provide manual and/or automation testing of features and capabilities of platform and/or...
Flexible hours
Samprasoft
Chicago, IL
20 hours ago
QA Engineer
...Job Title: QA Engineer Request-ID: 83898-1 Location: Chicago, IL Duration: 06+ Months Pay Range: $35-41/Hour on W2 only... ...collaborating closely with developers and product teams to ensure high-quality software delivery. Key Responsibilities: Functional &...
Artech
Chicago, IL
3 days ago
QA/QC Engineer
...QA/QC Engineer Are you ready to grow your career with a company that values excellence and invests in its people? At Clune Construction... ...work. Excellence is at the core of everything we do, from the quality of our projects to the way we support our people. As an...
Contract work
Temporary work
Work at office
Local area
Flexible hours
Clune Construction
Chicago, IL
4 days ago
QA Engineer
$105.6k - $120k
...with Technical Program Manager on defining success criteria • Providing feedback on design, usability, and user experience from a quality assurance perspective • Understanding continuous integration and delivery pipelines - Gitlab etc. • Contributing to test...
Flexible hours
Coates Group
Chicago, IL
3 days ago
Sr. QA Engineer
...We are seeking a highly skilled Senior QA Automation Engineer to lead the design, development, and maintenance of automated test frameworks... ..., product managers, and other QA engineers to ensure high-quality, reliable, and scalable software releases. Key Responsibilities...
Insight Global
Chicago, IL
3 days ago
QA Engineer
$105.6k - $120k
...Collaborating with Technical Program Manager on defining success criteria Providing feedback on design, usability, and user experience from a quality assurance perspective Understanding continuous integration and delivery pipelines – Gitlab etc. Contributing to test automation to...
Flexible hours
Coates-Group
Chicago, IL
3 days ago
Software Test Engineer
...Job Title : Software Test Engineer (Agriculture Experience Preferred) Location : Oakbrook, IL , Onsite Job Type : Contract Job Description We are looking for a Software Test Engineer with expertise in Python automation testing and experience in agricultural...
Contract work
Kasmo Global
Oak Brook, IL
3 days ago
Automation Test Engineer
...Test Automation Engineer Designing and developing test automation scripts. Convert manual tests to automated tests. Using test automation guidelines. Researching issues in software through testing. Collaborating with QA Analysts and Software Developers...
Software Technology Inc
Chicago, IL
4 days ago
Quality Engineer
$120k - $140k
Must Have Technical/Functional Skill • create and execute enterprise, web-based, services and client server applications test plans and cases and log defects. • Strong analytical skills in assessing user, functional and technical requirements, as well as working understanding...
Tata Consultancy Services
Chicago, IL
2 days ago
Quality Engineer
$79k - $119k
...broad supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop... ...Education: ~ Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field. Work Experience...
Minimum wage
Work experience placement
Local area
Worldwide
Medline
Chicago, IL
2 days ago
Quality Engineer
$72k - $85k
...dynamic, fast paced and growing workplace to continuously learn and thrive, we want to hear from you! We are looking for a Quality Engineer to join the team at our Norridge, IL location. Are you looking for a great place to work with an amazing culture and opportunities...
Full time
Monday to Friday
Day shift
NSi Industries LLC
Norridge, IL
20 hours ago
Quality Engineer II
$40 - $44.92 per hour
...Title: Quality Engineer II Location: Chicago, IL, 60629 Duration: 6+ Months with possible extension. Pay Range: $40-44.92/hr This position is 100% onsite at the Chicago bakery, working 3rd shift to start (11pm to 7am, M-F) with a possible move to 2nd shift...
Shift work
Night shift
Weekend work
Day shift
Afternoon shift
Artech
Chicago, IL
20 hours ago
Quality Engineer
$70k - $90k
...Legrand has an exciting opportunity for aQuality Engineerto join theLighting Division Focal Point Teamin Chicago, IL.Looking for a Quality Engineer with high aptitude and energy to implement and execute quality system best practices in the manufacturing, supplier, and new...
Temporary work
For contractors
Work experience placement
Worldwide
Legrand NA
Chicago, IL
4 days ago
Quality Engineering Temp
$75k
...education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data. Supplier Quality Engineer II ~ Estimated annual base pay: $75,000.00 (minimum) - $97,000.00 (midpoint) - $120,000.00 (maximum) ~ All members...
Permanent employment
Temporary work
Local area
Flexible hours
Woodward HRT/MPC
Niles, IL
1 day ago
Quality Engineering Temp
...Quality Engineer The Quality Engineer plays a critical role in ensuring that products and processes meet established quality standards and regulatory requirements. The quality engineer will supervise, and coordinate activities of workers engaged in inspection and testing...
Temporary work
Thunderbird
Park Ridge, IL
1 day ago
QUALITY ENGINEER
...Quality Engineer We are looking for a Quality Engineer to assist the Director of Quality Assurance in managing the quality function for both our continuous process and job shop manufacturing environments. We are ISO 9001-2008 certified and looking to become TS-certified...
Shift work
Direct Staffing Inc
Chicago, IL
4 days ago
Quality Engineering S
...SCOPE: The Supplier Quality Engineer is responsible for developing and executing supplier quality strategies that ensure the delivery of high-quality materials, components, and services. This role manages supplier qualification, performance monitoring, and continuous...
Work at office
Cognesense
Hillside, IL
2 days ago
Quality Engineer
$61k - $80k
...Quality Engineer Morristown, Tennessee, United States $ 61,000.00 - 80,000.00 (US Dollar) About the job Quality Engineer Experience level: Associate Experience required: 3 Years Education level: High school or equivalent Job function: Administrative...
Work at office
Relocation package
Staffworthy
Oak Brook, IL
1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality Engineer. Be the first to apply!