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
- ...Business in Pleasant Prairie, WI is seeking a Quality Control Lead Inspector to oversee inspection operations in a regulated medical tubing environment. This leadership role... ...ideal candidate will have strong knowledge of ISO 13485, FDA GMP regulations, and GMP, with 3+...Quality
- ...Unit Manager to lead our Medical Tubing and Converting areas... ...environment, operating within an ISO regulated quality system (ISO 13485) and an ISO certified... .... Partner with the Plant Leader and shared site resources... ...environment (medical device, pharmaceutical, healthcare...QualityMedical deviceFor contractors
- ...Quality LeaderAt DuPont, we are working on things that... ...in everyday technology devices from smartphones to electric... ...their best.PPC Quality Leader is an experienced... ...regulatory, food-safety, medical-packaging, and DuPont... ...Management System; sustains ISO 9001, FSSC 22000, and...QualityMedical deviceFlexible hours
- ...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
- ...Unknown We are looking for a Quality Control Lead Inspector to... ...inspection operations in a regulated medical tubing manufacturing... ...strong working knowledge of ISO 13485, FDA regulations, and Good Manufacturing... ..., preferably medical device or tubing extrusion. Proficient...QualityMedical deviceFull time
$90k - $120k
...deliver measurable gains in quality, cost, productivity, and sustainabilityPartner... ...technicians, engineers, and leaders to optimize cycle times,... ...leadershipExperience in medical device manufacturingStrong hands-on... ...ASME Y14.5)Familiarity with ISO 13485 and FDA 21 CFR 820Proven...QualityMedical device- ...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
- 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
- MPE-Inc is seeking a Quality Manager to lead the quality function at our Racine/Milwaukee area facilities. You will supervise quality... ..., CAPA, and continuous improvement initiatives in a fast-paced medical technology environment. Responsibilities include overseeing PPAP...QualityMedical deviceShift work
- ...Description Design Hire is seeking a Quality Manager to lead quality systems,... ...or management experience required. •Medical device manufacturing experience strongly preferred... ...regulated quality systems. •Experience with ISO 13485 preferred. •Background supporting...QualityMedical deviceTemporary workLocal area
- ...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
- ...Plans, coordinates, and directs quality control programs designed to... ...with established FDA and ISO standards.Investigate and address... ...seven years of experience in medical device manufacturing industry and in... ...preferred.Knowledge of ISO 13485 Quality Management System &...QualityMedical deviceWork at office
- ...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... ...preferably in a cleanroom or medical device manufacturing environment....QualityMedical deviceWork at officeShift work
- ...shape the future of electro‑mechanical medical device manufacturing. My client is seeking a driven... ...Collaborate with top‑tier engineering, quality, and regulatory teams Amazing bonuses... ...quality Ensure compliance with FDA, ISO 13485, and global regulatory standards Manage...QualityMedical device
- ...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
- ...winning portfolio of injectables, devices, and skincare products... ...operation of Merz North America Inc. Quality System and as directed.... ...years Quality experience in Medical Device, Pharmaceutical and/or... ...Management Software.Familiar with ISO 13485 Quality System Standards,...QualityMedical deviceFull time
- ...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
...Quality EngineerLocation: Sturtevant, WI Pay Rate: $40-50/hrThis position is responsible... ...manufacture of Electromechanical Devices (EMD) and non-EMD medical devices.Other duties as assigned:... ...Process Validation.Familiar with ISO 13485 Quality System Standards, FDA Quality...QualityMedical deviceLocal area- ...portfolio of injectables, devices, and skincare products... ...North America Inc. Quality System and as directed... ...the submission of a Medical Device Report (MDR) or... ...individual team membersEmpower leaders and employees to make... ...:Familiar with ISO 13485 Quality System Standards...QualityMedical deviceFull timeWork at officeLocal area
- ...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
- ...Integration (Process Validation) Engineer Medical Device Contract Manufacturer Flexible Films & Packaging... ...transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements, and internal quality standards...QualityMedical deviceContract workFlexible hours
$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$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$22.7 - $34.04 per hour
...For over three decades, Cirtec Medical has been a leading provider... ...complex Class II and III medical devices. We specialize in providing... ...team! Position Summary The Quality Control Document Technician... ...System Regulation (QSR) and ISO 13485. Salary Range: $22.70 - $34...QualityMedical deviceWork experience placementWork at officeFlexible hours- ...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
- 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
- About the RoleThe Multi-Office Leader, known internally as an Area Experience Leader, leads a portfolio of 4-6 retail offices and is responsible for delivering a consistent, high-quality client experience across every location. In this role, you’ll ensure each office is...QualityWork experience placementSeasonal workWork at officeNight shiftAfternoon shift
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