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Quality specialist • rosengarten

Zuletzt aktualisiert: vor 8 Stunden
Quality Assurance & Regulatory Affairs Specialist (m / f / d)

Quality Assurance & Regulatory Affairs Specialist (m / f / d)

EVIDENT Europe GmbHHamburg, Germany
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Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide.Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 cou...Mehr anzeigenZuletzt aktualisiert: vor 7 Tagen
Quality Assurance Specialist (m / w / d)

Quality Assurance Specialist (m / w / d)

Zucchetti DACHHamburg, Germany
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Mitarbeitenden eines der größten IT-Unternehmen Europas.Zucchetti bietet Software, Hardware und IT-Dienstleistungen für Unternehmen, die sich einen erheblichen Wettbewerbsvorteil sichern und sich f...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Quality Management Specialist (m / w / d)

Quality Management Specialist (m / w / d)

OTTO KRAHN Corporate Functions GmbH & Co. KGHamburg, DE
Die Otto Krahn Gruppe ist mit ihren Unternehmen in den Bereichen Kunststoffe, Spezialchemikalien und Keramik weltweit an 45 Standorten tätig und erzielt mit 1. Mitarbeitenden einen jährlichen Umsatz...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Software Quality Engineer (w / d / m) - Quality Assurance, Ingenieur

Software Quality Engineer (w / d / m) - Quality Assurance, Ingenieur

BSIHamburg, DE
Gemeinsam mit dem Entwicklungsteam die Testautomatisierung auf allen Ebenen der Testpyramide konzipieren, entwickeln und pflegen, um die Funktionalität, Integrität und Sicherheit der Anwe...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Senior Quality Assurance Engineer (m / w / d) - Quality Assurance, Ingenieur

Senior Quality Assurance Engineer (m / w / d) - Quality Assurance, Ingenieur

Wilken Software GroupHamburg, DE
New Work : Agile Teams, flexible Arbeitszeitmodelle und mobiles Arbeiten (Home-Office) für eine optimale Work-Life-Balance. Weiterbildung : Zugriff auf tausende Kurse unserer Lernplattform fü...Mehr anzeigenZuletzt aktualisiert: vor 13 Tagen
Quality Specialist (m / w / d)

Quality Specialist (m / w / d)

SECO Northern Europe GmbHHamburg, Hamburg, Deutschland
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Quality Specialist (m / w / d) bei SECO Northern Europe GmbH | softgarden.We always deliver the right solution to our customers, that is our commitment – and that is why we are looking for you as a str...Mehr anzeigenZuletzt aktualisiert: vor 15 Tagen
Quality Inspector

Quality Inspector

VHRHamburg, HH
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Management

Quality Management

tesaHamburg - tesa Werk Hamburg, Deutschland
Überwachung der Qualitätskonformität von Rohstoffen sowie Klebmassen.Eigenständige Durchführung von Freigabeprüfungen.Dokumentation und Beurteilung der Analyseergebnisse. Analytische Methodenentwick...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Assurance Manager

Quality Assurance Manager

WärtsiläHamburg, DE
Wärtsilä is an innovative technology company known for being a forerunner in the Marine and Energy markets.Every day, we – Wärtsilians - put our hearts and minds into turning Wärtsilä's purpose of ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Praktikum Quality Board

Praktikum Quality Board

G+J Medien GmbHHamburg, HH, DE
Du startest dein Praktikum im Bereich Quality Board befristet auf 3-6 Monate in Vollzeit.Du wirst in die Verifikationsarbeit eingeführt und lernst anhand aller im Quality Board angesiedelten Hefte ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Sales Specialist - Water Quality Testing (Germany)

Sales Specialist - Water Quality Testing (Germany)

PharmiwebHamburg, DE
Sales Specialist - Water Quality Testing (Germany).Are you passionate about making a difference in water safety and environmental health? Our client is looking for a motivated Sales Specialist.This...Mehr anzeigenZuletzt aktualisiert: vor 8 Tagen
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Quality Manager (m / w / d)

Quality Manager (m / w / d)

Düllberg Konzentra GmbH & Co. KGHamburg
Düllberg Konzentra ist Hersteller von ätherischen Ölen, Parfümölen und Aromen und liefert seine Produkte erfolgreich seit über 90 Jahren in die ganze Welt. Für den Bereich Qualitätsmanagement suchen...Mehr anzeigenZuletzt aktualisiert: vor 8 Stunden
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Software Quality Assurance Engineer fmx

Software Quality Assurance Engineer fmx

exmox GmbHHamburg, Hamburg, Germany
Exmox headquartered in Hamburg is an innovative AdTech company dedicated to crafting the next generation of performance marketing products. Our mission is to seamlessly connect advertisers with thei...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Specialist - System Integration and Test (m / f / d) - Vehicle Integration

Quality Specialist - System Integration and Test (m / f / d) - Vehicle Integration

MOIA Operations Germany GmbHHamburg, DE
Join us as a Quality Specialist - System Integration and Test (m / f / d) in our Vehicle Integration team on a shared journey that matters!. To make the vision of an autonomously driving mobility servic...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality CAPA Specialist (m / w / d)

Quality CAPA Specialist (m / w / d)

AbbottHamburg, State Not Indicated, Germany
Abbott ist ein weltweit führendes Unternehmen im Gesundheitswesen, das bahnbrechende wissenschaftliche Erkenntnisse nutzt und Lösungen zur Verbesserung der Gesundheit der Menschen entwickelt.Wir bl...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
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Quality & Test Engineer (m / w / d) - Quality Assurance, Ingenieur

Quality & Test Engineer (m / w / d) - Quality Assurance, Ingenieur

Cubic TransportationHamburg, DE
When you join Cubic, you become part of a company that creates and delivers technology solutions in transportation to make people’s lives easier by simplifying their daily journeys, and defen...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Specialist Quality & EHS (m / f / d)

Specialist Quality & EHS (m / f / d)

ColoplastHamburg, DE
Specialist Quality & EHS (m / f / d).We are searching for an experienced Specialist Quality & EHS, to support developing, implementing, and improving our QEHS management system.This position is part of...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Performance & Quality - Quality Auditing Representative

Performance & Quality - Quality Auditing Representative

AMMGroupHamburg, Hamburg, Germany
As a Quality Inspector, you will be responsible for performing quality inspections using the client's quality procedures (QSOI,DTN) and documenting compliance with product requirements and qual...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Coordinator Germany

Quality Coordinator Germany

World Courier (Deutschland) GmbHHamburg, Germany
Vollzeit
Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Quality Assurance & Regulatory Affairs Specialist (m / f / d)

Quality Assurance & Regulatory Affairs Specialist (m / f / d)

EVIDENT Europe GmbHHamburg, Germany
Vor 7 Tagen
Anstellungsart
  • Quick Apply
Stellenbeschreibung

Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.

Aufgaben

Quality

  • You are responsible for carrying out quality planning and risk analyzes in the course of development projects.
  • Supplier Management, -qualification and -audits - as well as the initiation of supplier development actions to maintain and continuously improve process and product quality are area of responsibility
  • You carry out internal root cause analyzes with subsequent initiation, monitoring and validation of corrective and preventive actions in collaboration with internal stakeholders
  • You are in charge of leading interdisciplinary project teams to introduce global process standards and key performance indicator requirements regarding the existing quality management system
  • You communicate with Evident organizations worldwide

Regulatory Affairs

  • Responsible for the coordination, evaluation and implementation of regulatory strategies and compliance programs through the review, consultation, training and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing etc) to fulfill their business goals in a compliant manner.
  • Supports an effective interface between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc) and ensures this interaction follows the established best practice model for Evident Business.
  • Provides review, consultation and support for regulatory agency communications for Evident in EMEA
  • Should have a working knowledge of and eager to expand knowledge of the applicable standards and regulations that apply to Evident MIS (product safety standards like IEC 61010-1, EMC standards, etc) so that that RA team can disseminate and filter this information to the respective disciplines inside Evident and the regulatory agencies that Evident works with to establish a consistent compliance approach.
  • Participates in product reviews and ensures that the RA team provides a compliance review of each stage gate review for both internal product designs or changes and OEM branding projects.
  • Must support and help effectively manage through the RA team any identified non-conformity or product liability discovery or incident and assists with customer compliance issues.
  • Act as a change agent for improvement initiatives
  • Perform all job duties in a safe manner and obey all safety policies and procedures
  • Work on all tasks related to ISO standards, regulatory or statutory requirements.

    • Qualifikation

  • B.S. / B.A in technical related field.
  • 5+ Years in QA / RA-Functions within the Life Science Industry
  • Profound knowledge of international regulatory requirements (ISO 9001, ISO 13485, EU MDR&IVDR, FDA, e.g.)
  • Profound knowledge in understanding and dealing with relevant directives and standards (such as the Machinery Directive, Low Voltage Directive, IEC 61010- / 60601-1, EMC, CE, etc.)
  • Knowledge in Product and Process Development requirements for MD / IVD like useability, software development, risk management, e.g.
  • Knowledge in dealing with material compliance requirements (RoHS, REACH, e.g.)
  • Experience with coordination and communication of reportable events with competent authorities and notified bodies.
  • Experience in communicating with Regulatory Agencies
  • Strategic thinking and ability to partner with internal stakeholders at senior levels is required.
  • Experience in negotiation of quality related contracts like QAA’s.
  • Must possess sound organizational skills, demonstrate attention to detail and an ability to multi-task
  • Proven experience in problem solving
  • Excellent verbal and written communication skills
  • Flexibility to Travel (20%) in Germany + international (5%)

    • Benefits

  • Flexible working hours, 50% remote work possible
  • 30 days of holiday per year
  • 13,5 salaries a year
  • Modern office and inspiring working environment
  • Subsidized meals in the neighborhood of our office (Stadtküche)
  • Public transport ticket (100% subsidized) or free parking space
  • Bike leasing
  • Subsidy fitness first gym
  • Employee Assistance Program to support your health, mental and emotional well-being
  • Comprehensive company pension scheme
  • Joint company events and activities

    • Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.

    Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.