Regulatory Quality Engineer - Medical Devices (FDA & ISO 13485)
ARCH
ARCH is seeking a Quality System Management Representative for the Elmhurst, IL and Kenosha, WI facilities to promote regulatory and quality system compliance. The role requires training personnel on the Quality System and regulatory standards, and ensuring processes are established, implemented, and maintained. Responsibilities include leading audits, CAPA, ECO, and MRB activities, developing metrics, and coordinating risk assessments and validation programs under FDA QSR 820 and ISO 13485. #J-18808-Ljbffr ARCH
- 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...Regulatory
- ...of injectables, devices, and skincare... ...OverviewAn experienced engineer, with a device... ..., and regulatory compliance are... ...electro-mechanical medical device manufacturing... ...and quality of current and... ...standards (e.g., FDA, CE Mark, IEC 60601 series, ISO 13485, GMP).Documentation...RegulatoryFull timeContract work
- Acts as a Quality System Management Representative... ...of applicable regulatory requirements and quality... ...regulatory requirements for medical devices such as FDA Quality System... ...guidelines, GDP, ISO 13485, ISO and other applicable... ...or bio-medical engineering is strongly preferred...Regulatory
$40 - $50 per hour
...Quality EngineerLocation: Sturtevant, WI... ...providing Quality Engineering and Technical... ...on manufacturing regulatory compliance issue... ...Electromechanical Devices (EMD) and non-EMD medical devices.Other... ...Validation.Familiar with ISO 13485 Quality System Standards, FDA Quality System...RegulatoryLocal area$89.8k - $114.1k
...product range includes engines, generators, power conversion... .../Kenosha, WI The Quality and EHS Engineer will... ...workplace, maintain regulatory compliance, improve product... .... Knowledge of ISO 9001 and/or ISO 14001 management... ...childbirth, or related medical conditions, genetic...RegulatoryWork at officeLocal area$85k - $100k
A recruitment firm is looking for a Quality Control Specialist in Pleasant Prairie, Wisconsin. The ideal... ...have over 5 years of quality experience in the medical device industry, with a strong understanding of ISO13485 and FDA standards. Responsibilities include executing...- ...Title : Quality Manager | Medical Device / ISO 13485 Basic Purpose and Function: The Quality... ...with ISO 13485, applicable regulatory requirements, customer... ...with Operations, Engineering, Supply Chain, and Customer... ...Experience working with FDA-regulated or medical device...Regulatory
- ...Quality Engineer IHot JobPPC - Pleasant Prairie - Pleasant Prairie... ...assurance for the medical tubing extrusion and... ...ensures compliance with ISO and cGMP standards... ...quality issues, ensure regulatory compliance, and enhance... ...experience in a medical device manufacturing...RegulatoryFull timeShift work
$80k - $90k
...Quality EngineerOur client, a leading medical device manufacturer based in the Milwaukee area with over... ...seeking a Quality Engineer to join their dedicated... ...operational efficiency.Supports regulatory and agency inspections,... ...knowledge of ISO 9001:2015 and IATFCompetitive...RegulatoryLocal areaFlexible hours- ...required the person to have Knowledge with FDA regulations for Medical Devices, and ISO 13485 Medical Device-QMS-Requirements for Regulatory Purposes and any other applicable... ...detection of problem areas, and delivering quality inspection outcomes. In addition, they are...RegulatoryWork at office
- ...Quality Engineer – Plant Operations For more than 100 years, Modine has solved the toughest thermal management... ...and corrective actions. Ensure compliance with ISO, ASHRAE, and other relevant industry and regulatory standards. Required Education & Qualifications...RegulatoryTemporary workInternshipWorldwide
- ...Sr. Process Engineer Location: Racine, Wisconsin Step into a... ...future of electro‑mechanical medical device manufacturing. My client... ...with top‑tier engineering, quality, and regulatory teams Amazing bonuses and... ...quality Ensure compliance with FDA, ISO 13485, and global regulatory...Regulatory
- ...Hire is seeking a Quality Manager to lead... ...support external regulatory or customer audits... ...with operations, engineering, and production teams... ...required. •Medical device manufacturing experience... ...knowledge of FDA audit... ...•Experience with ISO 13485 preferred. •Background...RegulatoryTemporary workLocal area
- ...portfolio of injectables, devices, and skincare... ...North America Inc. Quality System and as... ...changes to global regulatory requirements and relevant... ...Quality experience in Medical Device,... ...Software.Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations...RegulatoryFull time
- ...Partnerships, Inspired Foresight, and Quality-Assured Personal Connections... ...standards, including ISO 13485. Whether you're just... ...Adhere to safety, quality, and regulatory protocols at all times... ...Experience in regulated industries (medical devices, dental, pharma) is highly...RegulatoryFull timeCurrently hiringShift workAfternoon shift
- ...events and can support the Quality Department with Quality... ...if the submission of a Medical Device Report (MDR) or other... ...Vigilance Reports according to regulatory timelines.... ...Abilities: • Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations...RegulatoryWork experience placementWork at officeRemote work
- ...shift execution in a medical sterile packaging (converting... ...activities meet quality, regulatory, and safety... ...Ensure compliance with ISO 13485, ISO 11607, and internal... ...Partner with Quality, Engineering, Maintenance, and Training... ...cleanroom or medical device manufacturing...RegulatoryWork at officeShift work
- ...portfolio of injectables, devices, and skincare... ...North America Inc. Quality System and as... ...the submission of a Medical Device Report (MDR)... ...Reports according to regulatory timelines.Maintain... ...FunctionalRequired:Familiar with ISO 13485 Quality System Standards, FDA Quality System...RegulatoryFull timeWork at officeLocal area
- ...Manager, Design Quality – Lifecycle Management... ...knowledge of Medical Devices and Combination Products... ...Injectors, PFS FDA/EU regulations on... ...preparation of regulatory inspections and... ...’s degree in engineering, science, or other... ...Working knowledge of ISO 13485, ISO 14971, 21...RegulatoryContract workLocal areaWorldwide
- ...through cutting-edge medical technology. Our... ...in design, engineering, and... ...seeking a dedicated Quality Manager to join... ...standards and regulatory requirements.... ...applicable ISO13485 and FDA requirements.... ...Maintain Medical Device Files and records per ISO 13485 requirements....RegulatoryFull timeRelocationShift work
- ...Quality EngineerFor over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive... ...suppliers in support of engineering projects.Key... ...continuous improvement.ISO 13485 backgroundMedical Device...Work at office
- ...Manager to lead our Medical Tubing and... ...operating within an ISO regulated quality system (ISO 13485) and an ISO certified... ...EHS, Maintenance, Engineering, and CI/OpEx) to solve... ...quality, labor, and regulatory requirements; maintain... ...(medical device, pharmaceutical, healthcare...RegulatoryFor contractors
- ...and electromechanical devices-we leverage innovation... ...The Compliance Engineer is responsible for ensuring... ...meet applicable global regulatory, safety, and... ...Sustaining Engineering, Quality, and external certification... ...Comprehensive benefits package: medical, dental, and vision...RegulatoryLocal areaFlexible hours
- ...Packaging Engineer Packaging Engineering is responsible for designing... ...packaging systems used for medical devices and supplies. The Packaging... ...initiatives. Support of regulatory initiatives including MDR.... ...preferred ~ Knowledge of ISO, ASTM, and ISTA standards...RegulatoryWork experience placementFlexible hours
- ...help ensure compliance with regulatory and company standards. Once a... ...Partner with Production, Engineering, Facilities, and Human Resources... ...PowerPoint) ~ Knowledge of ISO 14001 and/or ISO 45001 standards... ...Comprehensive benefits package including medical, dental, and vision insurance...RegulatoryFull timeTemporary workWork at officeLocal area
$75k - $80k
...packaging goals are achieved safely and efficientlyDrive food safety, quality, and employee safety initiativesMonitor productivity, labor... ...optimizationMaintain compliance with GMPs, HACCP, and all regulatory requirementsWhat We're Looking ForBakery manufacturing...RegulatoryImmediate start- The Regulatory Affairs (RA) Manager of Global Labeling... ...-end alignment of medical device labeling,... ...authorities (e.g., FDA, EU MDR) and environmental... ...a controlled Quality Management System.... ...symbols (e.g., ISO 15223-1, ISO 7000)... ...with R&D, Packaging Engineering, and Supply Chain...RegulatoryFull timeTemporary workWork experience placementLocal areaImmediate startWork from homeWorldwide
- ...manufacturing excellence? We’re looking for a Quality Engineer to join our team and play a key role in... ...across the automotive, consumer, medical, healthcare, electronics, and industrial... ...and maintain compliance with IATF 16949, ISO 9001, and ISO 14001 standards Conduct...Work at officeWorldwideRelocation package
- ...supporting environmental stewardship and regulatory compliance across capital project... ...Collaborate with client stakeholders, engineering firms, LEED teams, OEMs, and contractors... ...construction projects. Familiarity with ISO 14001 standards (preferred). Experience...RegulatoryFull timeFor contractorsLocal area
- ...and packaging materials, and we’re growing! As an International Trade Compliance Specialist, tackle regulatory hurdles, find tariff savings and bring Uline’s high quality products to international destinations.Careers Packed with Potential. Backed by 45+ years of...RegulatoryFull time
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