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Quality assurance specialist • rosengarten

Zuletzt aktualisiert: vor 2 Tagen
Quality Assurance & Regulatory Affairs Specialist (m / f / d)

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

EVIDENT Europe GmbHHamburg, Germany
Quick Apply
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 18 Tagen
Field Quality Assurance Specialist (m / w / d)

Field Quality Assurance Specialist (m / w / d)

Amazon Deutschland W12 Transport GmbH - J53Hamburg, DE
Über unsOperations is the heart and soul of everything Amazon does.As member of the ACES (Amazon Customer Excellence Systems) and Quality team, you will solve complex challenges and contribute to t...Mehr anzeigenZuletzt aktualisiert: vor 2 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
Quality Assurance Engineer Produktentwicklung

Quality Assurance Engineer Produktentwicklung

LESERHamburg, DE
Hamburg suchen wir zum nächstmöglichen Termin einen .Quality Assurance Engineer Produktentwicklung.LESER freut sich über Bewerbungen von Menschen gleich welchen Geschlechts, Religionszugehörigkeit,...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
IT Software Tester (m / w / d) Quality Assurance

IT Software Tester (m / w / d) Quality Assurance

The Creative ClubHamburg, Hamburg, Deutschland
Quick Apply
IT Software Tester (m / w / d) Quality Assurance bei The Creative Club | softgarden.IT Software Tester (m / w / d) Quality Assurance. Voll- oder Teilzeit / unbefristet.EMPOWERING PEOPLE TO BRING CREATIVE ID...Mehr anzeigenZuletzt aktualisiert: vor 12 Tagen
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Field Quality Assurance Specialist

Field Quality Assurance Specialist

UndisclosedHamburg, Hamburg, DE
Operations is the heart and soul of everything Amazon does.Sind Sie bereit, sich zu bewerben Vergewissern Sie sich, dass Sie alle Verantwortlichkeiten und Aufgaben im Zusammenhang mit dieser Stelle...Mehr anzeigenZuletzt aktualisiert: vor 3 Tagen
Quality Assurance Specialist (m / w / d)

Quality Assurance Specialist (m / w / d)

Zucchetti DACHHamburg, Germany
Quick Apply
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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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 24 Tagen
Field Quality Assurance Specialist (m / w / d)

Field Quality Assurance Specialist (m / w / d)

Amazon Deutschland S38 Transport GmbH - L98Hamburg, DE
Über unsOperations is the heart and soul of everything Amazon does.As member of the ACES (Amazon Customer Excellence Systems) and Quality team, you will solve complex challenges and contribute to t...Mehr anzeigenZuletzt aktualisiert: vor 4 Tagen
  • Gesponsert
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
Quality Assurance Engineer (m / w / d)

Quality Assurance Engineer (m / w / d)

Seehoff GmbHHamburg, Hamburg, DE
Über uns Die Seehoff GmbH ist der Spezialist für die Vermittlung von IT-Experten in Festanstellung in Hamburg und Umgebung. Für einen Kunden mit Sitz in Hamburg, suchen wir aktuell einen Quality Ass...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Assurance Engineer (f / m / d)

Quality Assurance Engineer (f / m / d)

ng-voice GmbHHamburg, DE
Committed to building the next generation of 100% software-based mobile networks, combining DevOps with telecommunications expertise, ng-voice is creating innovative mobile infrastructure solutions...Mehr anzeigenZuletzt aktualisiert: vor 29 Tagen
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Product Quality & Safety Specialist

Product Quality & Safety Specialist

VestasHamburg, Hamburg, Germany
Vollzeit
Do you want to be a part of a greener future? Are you looking for an exciting opportunity in a growing industry? Then, have a look at this career opportunity to join Vestas!.Vestas Technology & Ope...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Softwaretester (m / w / d) - Quality Assurance, Ingenieur

Softwaretester (m / w / d) - Quality Assurance, Ingenieur

MAC IT-SolutionsHamburg, DE
Unser Team der Qualitätssicherung sucht zum nächstmöglichen Zeitpunkt eine : n Softwaretester : in als Verstärkung für die Standorte Flensburg oder Hamburg!.Der Schwerpunkt uns...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Quality Assurance Engineer

Senior Quality Assurance Engineer

StatistaHamburg
Location Hamburg Working Model Full-time Job category Product & IT.Senior Quality Assurance Engineer (m / f / d).Location Hamburg Working Model Full-time Job category Product & IT.At Statista, we’re al...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Praktikant / Werkstudent Audit & Assurance - Softwaretesting (m / d / w) - Quality Assurance, Ingenieur

Praktikant / Werkstudent Audit & Assurance - Softwaretesting (m / d / w) - Quality Assurance, Ingenieur

DeloitteHamburg, DE
Ob im Business Audit & Assurance, Risk Advisory, Tax & Legal, Financial Advisory oder Consulting : Wir bei Deloitte unterstützen unsere weltweiten Mandanten dabei, sich kontinuierlich w...Mehr anzeigenZuletzt aktualisiert: vor 24 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
Quality Assurance Manager (m / w / d)

Quality Assurance Manager (m / w / d)

Merck KGaA, Darmstadt, GermanyHamburg, Germany
Als Mitabeiter (m / w / d) der Abteilung Qualitätssicherung unterstützen Sie das Team bei der Aufrechterhaltung und Weiterentwicklung des Qualitätsmanagementsystems nach GMP-Richtlinien.Ihre Hauptaufga...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Control / Assurance Specialist – Mechanical Industry (Jigs & Tools)

Quality Control / Assurance Specialist – Mechanical Industry (Jigs & Tools)

AMMGroupHamburg, Hamburg, Germany
We are seeking a meticulous and experienced Quality Control / Assurance Specialist to ensure high standards in the production of jigs and tools, with a strong focus on process quality, compliance, ...Mehr anzeigenZuletzt aktualisiert: vor 5 Tagen
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(Junior) Softwaretester (m / w / d) - Quality Assurance, Ingenieur

(Junior) Softwaretester (m / w / d) - Quality Assurance, Ingenieur

TQGHamburg, DE
TQG ist ein erfolgreiches mittelständisches Beratungs- und Softwareunternehmen.Seit über 30 Jahren setzen wir Trends und Standards für strukturierte und übergreif...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 18 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.