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Quality Assurance Manager (m/f/d)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Support, Engineering

Projektbeschreibung

REFERENCE NUMBER:

409638/11

MY DUTIES:

-Responsible for the coordination of risk management files according to ISO 14971
-Define, maintain and implement relevant and state of the art necessary processes within responsibility and in accordance with current regulations and ensure respective approval
-Responsible to create training documents, perform trainings on Quality Assurance topics
-Ensure quality assurance and compliance by providing support in relevant areas for various stakeholders
-Review, approve or release of risk management related documents, such as documentation of verification and validation activities (plan and reports) in projects and changes
-Support planning and implementation of compliance for the product documentation (technical file) according to current international standards
-Support design and development of new products with regards to compliance according to current international standards
-Responsible for the review of compliance submissions to notified bodies
-Support of tests regarding software, cleaning validation, sterilization
-Support the NCR and CAPA process
-Substitute for support or coordination of technical tests regarding compliance with the relevant standards (biocompatibility, food contact, IEC 60601-1, EMC, environmental and packaging test, usability, human factors engineering)

MY QUALIFICATIONS:

-Technical or equivalent education in the life science area (Apprenticeship, hands-on)
-Further education in life science (medical technology) and / or quality management
-Specific training in quality assurance / risk management required (e.g., ISO 13485, ISO 14971) and / or regulatory affairs
-English spoken and written fluently at least at advanced level or several years of language application in an international field of life science
-Experience in a comparable industry especially in the life science area
-Experience in the practical application of ISO 13485 and ISO 14971 mandatory
-Experience in dealing with the European Directive 93/42 EEC
-Knowledge of MDR / MDD
-Experience in dealing with notified bodies

MY BENEFITS:

-A highly motivated team and an open way of communication

PROJECT INFORMATION:

Our client is a very successful company and a global player in a number of industries. Due to its flat hierarchies and lean structures, our client offers significant potential for further development.

REMUNERATION DETAILS :

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Sevda Karakas

Reference number
409638/11

Contact
E-Mail: sevda.karakas@hays.ch

Projektdetails

  • Einsatzort:

    Zug, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Befristet

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland