Quality Leader - ISO 13485 Medical Devices
Vonco Products, LLC
Vonco Products, LLC is seeking a Quality Manager to lead the ISO 13485 quality system and ensure compliance with regulatory and customer requirements in a medical device environment. This role partners with Operations, Engineering, Supply Chain, and Customer Service to drive a culture of quality and continuous improvement. The ideal candidate will oversee CAPA, nonconformance, risk management per ISO 14971, supplier quality, internal/external audits, and regulatory inspections. #J-18808-Ljbffr Vonco Products, LLC
- ARCH is seeking a Quality System Management Representative for the Elmhurst, IL and Kenosha, WI facilities to promote regulatory and quality... ..., developing metrics, and coordinating risk assessments and validation programs under FDA QSR 820 and ISO 13485. #J-18808-Ljbffr ARCHQualityMedical device
- ...EXALTA Group in Wisconsin (Kenosha) seeks a senior quality auditor to ensure compliance with FDA QSR and ISO 13485, lead internal and supplier audits, and drive... ...in manufacturing. The role requires 5+ years of medical device QA experience, strong documentation control, and...QualityMedical device
- ...Quality Leader At DuPont, we are working on things that matter, whether... ...in everyday technology devices from smartphones to electric... ...customer, regulatory, food-safety, medical-packaging, and DuPont quality... ...Management System; sustains ISO 9001, FSSC 22000, and applicable...QualityMedical deviceFlexible hours
- ...required the person to have Knowledge with FDA regulations for Medical Devices, and ISO 13485 Medical Device-QMS-Requirements for Regulatory Purposes... ...activities, detection of problem areas, and delivering quality inspection outcomes. In addition, they are in charge of planning...QualityMedical deviceWork at office
- Title : Quality Manager | Medical Device / ISO 13485 Basic Purpose and Function: The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving the organization's Quality Management System (QMS) in accordance with ISO 13485, applicable...QualityMedical device
- Acts as a Quality System Management Representative for the Elmhurst (IL) and Kenosha (WI)... ...all applicable regulatory requirements for medical devices such as FDA Quality System Regulation - 21 CFR 820, GMP guidelines, GDP, ISO 13485, ISO and other applicable regulatory...QualityMedical device
- ...winning portfolio of injectables, devices, and skincare products... ...improving electro-mechanical medical device manufacturing, process... ...to improve productivity and quality of current and future products... ..., CE Mark, IEC 60601 series, ISO 13485, GMP).Documentation Develop...QualityMedical deviceFull timeContract work
- ...Differential Join EXALTA Group and help ensure the quality of high-precision components used in the medical device industry. We're looking for a detail-oriented... ...Ensure all records and documentation comply with ISO 13485, FDA, and company quality requirements Meet...QualityMedical deviceRelocation packageMonday to FridayShift workAfternoon shift
$90k - $110k
...specifications, geometry dimensions and quality standards including... ...other organizational key leaders/departments to achieve cohesive... .... Proven track record in medical device design and development.... ...ASME Y14.5M. Knowledge of ISO 13485 Quality Management System &...QualityMedical device- ...shape the future of electro-mechanical medical device manufacturing. My client is seeking a driven... ...with top-tier engineering, quality, and regulatory teamsAmazing bonuses and... ...product qualityEnsure compliance with FDA, ISO 13485, and global regulatory standardsManage...QualityMedical device
- ...efficient shift execution in a medical sterile packaging (converting... ...production activities meet quality, regulatory, and safety requirements... .... Ensure compliance with ISO 13485, ISO 11607, and internal... ...in a cleanroom or medical device manufacturing environment....QualityMedical deviceWork at officeShift work
$154k - $231k
...leadership and direction to Quality team(s) to ensure quality and... ...regulations (e.g., QSR, PQS, GMP, ISO, ICH) pertaining to the... ...related to the design/operation of medical device or drug combination product... ...1CFR 820, 21CFR 210/211, ISO 13485, ISO 14971, MDSAP, and MDR)....QualityMedical deviceMinimum wageFull timeLocal areaWorldwide- ...world through cutting-edge medical technology. Our mission is to be the global leader in design, engineering, and... ...We are seeking a dedicated Quality Manager to join our team.... ...requirements. Maintain Medical Device Files and records per ISO 13485 requirements. If you...QualityMedical deviceRelocationShift work
- ...and significant improvements in safety, quality, delivery and cost by developing an excellent... ...ensure that the business complies with ISO, FDA, EPA, OSHA and all other legal... ...operations leadership experience Experience in Medical Device manufacturing and machining environment....QualityMedical deviceFull time
$40 - $50 per hour
...Title - Quality Engineer Location - Sturtevant, WI Pay Rate - $... ...the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices. Other duties as assigned... ...Process Validation. Familiar with ISO 13485 Quality System Standards, FDA...QualityMedical deviceLocal area$154k - $231k
Director Quality Assurance, Manufacturing (Project Management) Job... ...regulations (e.g., QSR, PQS, GMP, ISO, ICH) pertaining to the... ...related to the design/operation of medical device or drug combination product... ...1CFR 820, 21CFR 210/211, ISO 13485, ISO 14971, MDSAP, and MDR)....QualityMedical deviceMinimum wageLocal areaWorldwide$23 per hour
...Customer-Management, Statistical-Analysis, Quality-Improvement, Regulatory-Compliance,... ...complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance... ...Skills, and Abilities Familiar with ISO 13485 Quality System Standards, FDA Quality...QualityMedical deviceContract workWork at officeRemote work- ...Partnerships, Inspired Foresight, and Quality-Assured Personal Connections—we empower... ...procedures and quality standards, including ISO 13485. Whether you're just starting your... ...Experience in regulated industries (medical devices, dental, pharma) is highly desirable...QualityMedical deviceFull timeCurrently hiringShift workAfternoon shift
$85k - $100k
A recruitment firm is looking for a Quality Control Specialist in Pleasant Prairie, Wisconsin. The ideal candidate will have over 5 years of quality experience in the medical device industry, with a strong understanding of ISO13485 and FDA standards. Responsibilities include...QualityMedical device$90k - $110k
...Wisconsin, is looking for a dedicated individual to lead the medical device design and production management. The ideal candidate will have... ..., emphasizing timely project completion and adherence to quality standards. This role involves collaborating with cross-functional...QualityMedical device- Manager, Design Quality - Lifecycle Management Location: North Chicago, IL Top Skills... ...Experience or Education Working knowledge of Medical Devices and Combination Products (MDCP), such... ...required. Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation...QualityMedical deviceContract workLocal areaWorldwide
- ...through cutting-edge medical technology. Our mission is to be the global leader in design, engineering... ...into building medical device assemblies. This isn't... ...instructions, process flows, quality checklists, and... ...Working knowledge of ISO 9001 / 13485 quality systems Familiarity...QualityMedical deviceFull timeTemporary workWork at officeFlexible hoursShift work
$24 - $30 per hour
...turning machines, ensuring quality through inspections,... .... Experience in an ISO certified manufacturing... ...environment (automotive, medical, or aerospace).... ...is located in a medical device manufacturing facility... ...Group company, the global leader in workforce and business...QualityMedical deviceWeekly payContract workTemporary workWork at officeWeekend workDay shiftWeekday work- Medline is seeking a Director of Quality Assurance for our Waukegan, IL manufacturing site. You will lead QA/QC teams, align site processes with QSR/GMP/ISO standards, and drive regulatory compliance across product life cycles and regions of distribution. Collaborate with...QualityMedical device
- ...Engineering team, providing structured writing, document control, and quality system support to Automation, Utilities, and Facilities... ...technical writing experience in pharmaceutical, biotech, or medical device manufacturing Demonstrated experience authoring Deviation...QualityMedical deviceContract work
- Gilbane Building Company is seeking a Quality Control Manager to oversee quality assurance in Kenosha, Wisconsin. This role involves interacting with clients, managing quality assessments, and ensuring compliance with safety and design standards. The ideal candidate will...Quality
- CBRE Group, Inc. seeks a Quality and Compliance Manager to lead the QA/QC team at a Life Sciences site in Pleasant Prairie, WI. This fully onsite role includes supervising staff, coordinating daily activities, and ensuring compliance with client programs. You will drive...Quality
- CBRE seeks a Quality and Compliance Manager to supervise the quality assurance team at a Life Sciences site in Pleasant Prairie, WI. This full-time, on-site role requires leadership in audits, CAPAs, and investigations, with travel minimal. You will implement compliance...QualityFull time
- ...temperature and humidity monitoring devices. Monitor system performance and ensure... ...within pharmaceutical, biotechnology, medical device, healthcare, or other... ...platforms is a plus. Exposure to cGMP, FDA, ISO, or other regulated quality systems preferred. Strong troubleshooting...QualityMedical deviceWork at office
- DuPont PPC, located in the Greater Chicago/Milwaukee region, seeks a PPC Quality Leader to oversee the site Quality function. You will own the Quality Management System, ensure ISO 9001 and FSSC 22000 compliance, and partner with Operations, Engineering, and Supply Chain...Quality
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