Quality Engineer
Katalyst Healthcares and Life Sciences
Job Summary:
Roles & Responsibilities:
Education & Experience:
- 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.
Vacancy posted 8 hours ago
Similar jobs that could be interesting for youBased on the Quality Engineer in Chicago, IL vacancy
$100k - $135k
...continue to grow. Job Description The Opportunity: We, at Flywire, are looking for an experienced Sr. QA Engineer I ideally with a background in FinTech The Quality Assurance team at Flywire is a group of engineers dedicated to improving the productivity of engineering...SuggestedFull timeTemporary workWork at officeImmediate start- ...10kA growing enterprise software organization is expanding its Quality Assurance team to support multiple flagship products used in large... ...initiatives. Strong work life balance, collaborative engineers, and real ownership over test quality make this a standout opportunity...SuggestedFull timeRemote work
- ...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 employee... ..., we welcome you to join our team and make an impact!The QA/QC Engineer is responsible for supporting quality assurance and quality control...SuggestedFull timeContract workTemporary workWork at officeLocal area
- Job Description: We are looking for an experienced Supplier Quality Engineer with 6-8 years of experience in supply chain, operations, engineering, or quality management within regulated industries such as Medical Devices, Pharmaceuticals, or Life Sciences. The candidate...Suggested
$100k - $150k
Hanson Values Integrity | Commitment | Quality | Relationships | InnovationIf you’re looking for a firm that encourages innovative thinking... ...and our environment.A Day in the Life of an Air Quality Engineer at HansonHere’s a snapshot of what you would do in this role:Lead...SuggestedFull timeInternshipLocal area- Job Summary:The Quality Engineer provides cross-divisional support for remediation efforts and is responsible for independently establishing and maintaining quality standards across a portfolio that includes medical devices, commodities, OTC drugs, and cosmetic products...
$101k - $152k
...minimal supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop... ...Quality Management.Requirements:EducationBachelor’s degree in Engineering, Science, Math or other related technical field.Work...Minimum wageFull timeLocal areaWorldwide- ...week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.As a Senior Quality Engineer, you will:Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).Lead risk...Full timeWork at officeRemote work3 days per week
- Job DescriptionThe Sr. Quality Engineer will report to the Technology Department. This role is responsible for leading a team of QA testers/engineers in testing our suite of products and software products to consistently deliver the highest quality solutions via SaaS,...Work experience placementNight shift
$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 Industry: Real Estate...Work at officeRelocation packageStaffworthy
Oak Brook, IL21 hours ago- ...The Judge Group, INC. in Chicago, IL or Toledo, OH seeks a Corporate Quality Assurance Compliance Specialist to own supplier qualification, compliance, and ongoing performance monitoring of raw materials, packaging, and third‑party operations. You will ensure suppliers...Relocation package
The Judge Group
Chicago, IL21 hours ago $70k - $90k
...Job Description Title: Supplier Quality Engineer Location: La Grange, IL Overview: Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company...Work at officeSterling Engineering
La Grange, IL3 days ago- ...backed by Bessemer Venture Partners, 8VC, Floodgate, Y Combinator, Elad Gil, and other top-tier investors. As a Senior AI Engineer, Quality , you will own the evaluation infrastructure that ensures our AI agents perform reliably at enterprise scale. This role is 10...Work at officeRemote workWork from homeFlexible hours
GrabJobs
Chicago, IL21 hours ago - ...to 7:00 am (Sat - Sun) with alternating 6:00 am - 10:00 pm/11:00 am - 3:00 pm (Friday) schedule Responsibilities Execute quality holds, investigations, and corrective actions Maintain accurate and compliant quality documentation and records Support food...Shift workWeekend workAfternoon shift
Axelon
Chicago, IL4 days ago $85k - $110k
...resources of a national company, combined with the hands-on approach of a local company. POSITION SUMMARY We are seeking a Quality Engineer who is passionate about construction quality, enjoys being in the field, and thrives working alongside project teams to...Work experience placementLocal areaVisa sponsorshipWork visaPepper Construction
Chicago, IL4 days ago- ...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, IL4 days ago - ...Quality Control Specialist Responsible for assisting Business Unit Manager in expediting disposition of all non-conforming product... ...lead improvement / reduction efforts Ability to interpret engineering drawings, diagrams and confer with management and engineering...
Midwest Aerospace Casting
Blue Island, IL3 days ago $72k - $85k
...Quality Engineer Focused on the electrical and network infrastructure markets, NSI continues to outpace the industry with unprecedented growth. We are all about "Making Connections" and we know our future success depends on the collective talents and experiences of...Full timeMonday to FridayDay shiftNSi Industries LLC
Chicago, IL1 day ago$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 workNight shiftWeekend workDay shiftAfternoon shiftArtech
Chicago, IL21 hours ago- ...Quality Engineer As a Quality Engineer, you will perform a variety of technical, administrative, and programmatic analyses of supplier industrial processes. Location of position: GSA; Federal Acquisition Service (FAS); Office of Shared Services Delivery; Office of...Work at office
US Government Jobs
Chicago, IL1 day ago - ...Quality Engineer Location: Remote Interview Mode: 2 rounds of virtual interview Type: Long term contract Job Description Minimum Position Qualifications - • 6+ years of software product development and delivery experience. • 5+ years of ETL testing/...Long term contractRemote work
RIT Solutions, Inc.
Chicago, IL9 hours ago $105.4k - $207.8k
Position Summary Senior QA Engineer -AI & EngineeringJoin our AI & Engineering team in transforming technology platforms, driving... ...-facing or industry role.4+ years’ experience driving the quality assurance processes and gaining delivery and buy-in from executive...Local areaVisa sponsorshipFlexible hours$90k - $110k
...Competitive Salary and Bonuses Lead all quality functions About Our Client Our client, an aerospace manufacturer based in the western suburbs, is seeking a Sr. Quality Engineer to lead their laboratory operations. Serving prominent OEMs like Boeing, Raytheon...Local areaMichael Page International Inc.
Chicago, IL2 days ago- Job Description: Proven use of 1 or more mobile development and emulator packages (Android SDK, iOS XCode, SWIFT, Calabash, Appium, GENYmotion) Exposure to commercial mobile manual/automation test management packages (Perfecto, Experitest-SeeTest, MobileLabs, SauceLabs,...
$109.25k - $149.5k
...headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.SUMMARYThe Staff Design Quality Assurance Engineer (DQA) is a subject matter expert responsible for the efficient and compliant support of New Product Development (NPD) and...Full timeTemporary work$121.39k - $151.56k
...with product managers, developers, and DevOps teams to ensure quality standards and testing coverage (10%). Stay current with evolving... ...degree in Information Technology, Computer Science, Computer Engineering, Electronics Engineering, or a related field, or a foreign...Full timeTemporary workWork at officeRemote workFlexible hours$96.51k - $127.89k
...eligible for S&C’s annual incentive plan (AIP), subject to eligibility criteria. Join Our Team as a Manufacturing Quality III!Manufacturing Quality Engineer III is responsible for managing quality-focused projects aimed at improving manufacturing processes and product...Temporary workWork at officeLocal areaWorldwideFlexible hours$114.7k - $194.9k
...partners, we serve the world’s most sophisticated clients using leading technology and exceptional service. Position: Principal, Quality Engineering Location : Chicago, IL, USA Experience : 14–18 Years (Minimum 8 years in Quality Engineering and 5 years in leadership role)...For contractorsWorldwideVisa sponsorshipWork visaFlexible hoursNorthern Trust
Chicago, IL21 hours ago$97k - $143k
Eaton’s Electrical Engineering Services & Systems Division (EESS) is currently seeking an Electrical Construction Quality Engineer (QA/QC)This role can be based remote within the United States with up to 75% travel.The Electrical Construction Quality Engineer (QA/QC) is...For subcontractorH1bLocal areaRemote workVisa sponsorshipFlexible hoursNight shift$99k - $164.8k
...helping to provide an experience to our stakeholders that delivers on our promises.POSITION SUMMARY:Kemper is seeking a Data Quality Engineer specializing in Data Testing and Quality Engineering to design, implement, and optimize enterprise data validation frameworks...Full timeWork experience placementWork at officeLocal areaRemote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Engineer. Be the first to apply!
Related searches
- supplier quality engineer Chicago, IL
- customer quality engineer Chicago, IL
- senior data quality engineer Chicago, IL
- program quality engineer Chicago, IL
- quality systems engineer Chicago, IL
- quality engineer remote Chicago, IL
- quality assurance quality control engineer Chicago, IL
- advanced quality engineer Chicago, IL
- senior manager quality engineering Chicago, IL
- quality engineer Chicago, IL