Senior Quality & Regulatory Leader - ISO 13485/9001, Mfg
Konik
Konik in Minneapolis is seeking a Quality & Regulatory Manager to lead quality assurance, regulatory compliance, and continuous improvement initiatives at its Minnesota facility. This senior leadership role oversees the Quality Management System, internal auditing, product inspection, validation activities, supplier quality, and the quality team. The ideal candidate brings extensive quality leadership experience in plastic injection molding and regulated manufacturing environments, with the #J-18808-Ljbffr Konik
- ...partners with a Minnesota manufacturer to recruit a Quality & Regulatory Manager for the Minneapolis facility. This senior role directs quality assurance, regulatory... ...improvement across the site to ensure robust QA and ISO alignment. The ideal candidate has extensive...QualitySeniorRegulatory
- Gradian Thermal Solutions seeks a Quality Manager to lead and improve our ISO 9001 compliant QMS in a data-center HVAC manufacturing setting. You will oversee... ...and supply chain. You will ensure product quality, regulatory compliance, and customer satisfaction, guiding...QualityRegulatory
- Nextern, Inc. is looking for a Quality Systems Manager to oversee the Quality Management System for its US sites. This role entails managing... ..., defining performance metrics, and ensuring compliance with ISO 13485 and FDA GMP standards. The ideal candidate should have a...QualitySenior
- Gradian Thermal Solutions seeks a Quality Manager to lead and continuously improve our ISO 9001 certified QA/QC program for data-center cooling products. You will... ...readiness, and reporting KPIs while ensuring regulatory and performance standards for liquid cooling systems...QualityRegulatory
- Konik, based in Minneapolis, MN, is seeking a Quality & Regulatory Manager to lead quality assurance, regulatory compliance, and continuous improvement... ...plastic injection molding and regulated manufacturing environments, with a focus on ISO compliance, new #J-18808-Ljbffr KonikQualitySeniorRegulatory
- Quality Auditing LLC seeks an experienced Medical Device Auditor for contract work in the greater Minneapolis area. The role focuses on... ...thorough first- and second-party quality system audits against ISO 13485, MDSAP, FDA QMSR, and EU MDR, with professional opening/...QualitySeniorContract work
- A leading recruiting firm is seeking a Senior Supplier Quality Engineer in Minneapolis. This long-term contract role focuses on supplier qualification... ...quality or quality engineering, with a strong knowledge of ISO 13485 and FDA regulations. #J-18808-Ljbffr Staftonic LLCQualitySeniorLong term contract
- Spectrum Plastics Group in Minneapolis, MN is seeking a Quality Assurance Manager to ensure regulatory compliance and drive quality improvements across the... ...develop inspection procedures, and mentor a team to uphold ISO and FDA standards. Responsibilities include reading...QualityRegulatory
- Spectrum Plastics Group is seeking a Quality Assurance Manager to ensure regulatory compliance (ISO & FDA) and maintain robust QA systems. The role involves leading the QA team, improving reporting processes, and guiding staff on quality standards across the site. You...QualityRegulatory
- Spectrum Plastics Group is seeking a Quality Assurance Manager to ensure regulatory compliance and drive quality improvements in a manufacturing setting. You... ...QA, with strong analytical and communication skills and experience with ISO standards. #J-18808-Ljbffr DupontQualityRegulatory
- ...experienced professional capable of managing Quality and Compliance activities for GCP/GVP... ...FDA BIMO Compliance, maintenance of ISO 9001:2015, ISO 13485:2016, ISO 27001:2022, ISO 27701:2019... ...Medical Officer and Global Head of Regulatory and Quality. The Position is office-...QualitySeniorRegulatoryContract workWork at office
- Meditrial is seeking an experienced quality and regulatory professional to lead GCP and GVP compliance efforts, audit strategy, and QA oversight. The role partners with clinical development, operations, and regulatory affairs to ensure ongoing compliance across all Meditrial...QualitySeniorRegulatory
- H2O Innovation is looking for a Quality Manager to enhance quality systems within its Water Technologies & Services Division in Minneapolis... ...will have experience in supplier quality engineering and ISO 9001 systems. The position offers a comprehensive benefits package...Quality
- Micro-Matics Inc. is a leader in providing high quality precision Swiss... ...environment. The QMS / ISO Compliance Specialist... ...customer requirements, and regulatory expectations. This... ...Standardization ISO 9001, International... ...Standardization ISO 13485, or customer-specific...QualityRegulatory
- Senior Quality Engineer (CAPA / QMS Focus)Location: Twin Cities, MNFull-time | OnsitePosition... ..., and ensure ongoing compliance with regulatory and internal quality standards.This... ...with applicable standards (e.g., ISO 9001, ISO 13485, AS9100, or industry-specific regulations...QualitySeniorRegulatory
- ...Senior Quality Assurance Engineer The Senior Quality Assurance Engineer for Beckman Coulter... ...Ensure compliance with applicable regulatory agency requirements, published standards... ...regulatory requirements, such as FDA, ISO 13485 standards. Ensure the product Design...QualitySeniorRegulatoryLocal area
- Brio Group is seeking a Senior Quality Engineer to provide leadership and technical support in... ..., Engineering, Manufacturing, and Regulatory teams to ensure compliance and client satisfaction... ...manufacturing, with strong knowledge of FDA and ISO 13485. #J-18808-Ljbffr Brio GroupQualitySeniorRegulatory
$155k
...highly talented and self- motivated Senior Insurance Technology Leader to join it in advancing the technological... ...outcomes, operating efficiency, regulatory needs, customer experience, and... ...engineering outcomes, operational efficiency, quality, cost, speed, and customer value....QualitySeniorRegulatoryFull timeLocal area- ...Medical in Minneapolis, MN is seeking a strategic Regulatory and Design Assurance leader to guide regulatory and quality initiatives across the organization. The role... ...submissions, ensures compliance with FDA QSR, ISO 13485, and EU MDR, and leads a high-performing team...QualityRegulatory
- ...role is responsible for ensuring that product designs meet quality, regulatory, and customer requirements, with a strong focus on risk management... ...with applicable regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC standards as applicable). Participate in...QualitySeniorRegulatoryWork at office
- The Senior Quality Engineer will provide quality engineering leadership and technical support... ...Operations, Engineering, Manufacturing, and Regulatory teams to ensure products and processes... ...and quality systems comply with FDA, ISO 13485, MDD/MDR, and applicable customer and...QualitySeniorRegulatory
- ...Matics Inc. in Minnesota is seeking a QMS / ISO Compliance Specialist to design, implement, and sustain the company’s Quality Management System. You will own... ...management reviews, ensuring alignment with ISO 9001, AS9100, and ISO 13485 requirements. You will partner with...Quality
$160k - $180k
...Job Description Title : Senior Manager of Quality and Regulatory Location : Plymouth, MN Job Type : Permanent Compensation... ...with applicable regulatory standards, including FDA QSR, ISO 13485, and EU MDR, with emphasis on regulatory and design...QualitySeniorRegulatoryPermanent employmentContract workWorldwideFlexible hours$94k - $150k
...Senior Regulatory Affairs SpecialistThe Senior Regulatory Affairs Specialist for Ultrasound collaborates... ...regulations and standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, and other... ...everybody everywhere has access to the quality healthcare that we all deserve. Do the...QualitySeniorRegulatoryFull timeWork at officeImmediate startWork visaRelocation package3 days per week$134.16k - $167.69k
...Description The Senior Quality Manager for Safco Products is responsible... ...System (QMS), ensuring regulatory compliance, and leading... ...programs. ~ Strong knowledge of ISO 9001 quality systems, continuous... ...Proven ability to influence leaders, drive organizational change...QualitySeniorRegulatoryWork at officeFlexible hours$108.45k - $156k
...Job Duties SENIOR DESIGN ASSURANCE ENGINEER – St. Jude Medical, an Abbott... ...completion, integrity, and regulatory and standards compliance while collaboratively... .... Ensure compliance with FDA, ISO 13485, ISO 14971, and internal Quality Management System (QMS) standards....QualitySeniorRegulatoryFull timeShift work- Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to lead strategic and operational regulatory activities for... ...with Regulatory, Technical Operations, Manufacturing, Quality, and Supply Chain to ensure global compliance. #J-18808-Ljbffr...QualitySeniorRegulatoryRemote job
- ...client is seeking an experienced Senior Microbiologist to provide... ...microbiological risk assessments, and quality system activities across the... ..., Quality, Supplier Quality, Regulatory Affairs, Research &... ...Familiarity with FDA regulations, ISO 13485, and other applicable global...QualitySeniorRegulatoryContract work
$110k - $160.91k
...advancing your career with a global leader in environmental consulting.... ...stakeholder engagement, and regulatory documentation and state... ...Electric Transmission Line Siting Senior Lead, you will serve as a... ...schedules, and deliver high-quality work products.Willingness to...QualitySeniorRegulatoryFull timeFixed term contractCasual workWork at officeRemote workFlexible hoursShift work- ...sponsorship available) About the Role As a Senior Supplier Engineer with Boston... ...collaborative role, you’ll partner with R&D, Quality, Operations, and Regulatory teams to integrate OEM, subsystem,... ...820 and MDR Auditor experience with ISO 13485 or similar quality systems Strong...QualitySeniorRegulatory3 days per week
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