Complaint Specialist 80 – 100 % (f/m/d)

Firma Hamilton Medical Inc.
Bereich Quality Management und Regulatory Affairs
Standort Domat/Ems (CH)
Home-Office Pensum Bis zu 60 %
Anstellungsart Mitarbeiter/in unbefristet
Referenznummer JR-3940

True to the vision “We drive innovation to improve people’s lives”, the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.

Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan – our solutions cover a multitude of patient groups, applications and environments.

How you can make a difference:

  • Act as the process owner for all incoming product complaints

  • Receive, register, and evaluate the complaint information for acceptance or rejection and justify the decision

  • Perform initial assessment for reportability and escalate complaints determined as reportable to Vigilance

  • Ensure that complaint investigations are appropriately performed and documented

  • Perform final review of the complaint inculuding final assessment based on investigation results or any additional information received

  • Determine the need for a CAPA request based on investigation findings

  • Perform process monitoring and measurement

  • Provide the complete IMDRF rating according to the complaint investigation report

That’s what you bring along:

  • Bachelor’s degree preferred, or equivalent combination of education and experience

  • 3+ years experience in processing complaints and performing triage and investigations, ideally in the medical device

  • Speaks/writes/reads English (fluent or native)

  • Profound experience with reading and interpreting device diagnostics and troubleshooting with medical devices with demonstrated experience in change management

  • Background in Post Market Surveillance and Health Hazard Evaluation process an advantage

  • Proven experience in working with complaint management systems (Ky2Help, Service-Now, ETQ, MasterControl, etc.)

  • Experience with intercultural teams in global matrix organization

  • Recognized expertise in electronics, electromechanics and/or biomedical

  • Experience with communication to local authorities (FDA, SwissMedic, BfArM, …) and medical device regulation (EU) 2017/745 as well as with American FDA laws a plus

  • International travel requirement up to 20%

Learn more about career opportunities at Hamilton at jobs.hamilton.ch.

Do you share our values and feel at home in a cooperative and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also various leisure activities and modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. Become part of a team where your skills are valued and innovative ideas are fostered. Interested? Then apply online using the "Apply now" button. If you have any questions, please contact us at jobs@hamilton.ch with the following details:

Reference: JR-3940/Contact: Ilaria Cerullo

Applications by post or e-mail can unfortunately not be considered.

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Vorholzeit für Brückentage zwischen Weihnachten und Neujahr

Eigene Pensionskasse mit Wahlmöglichkeit aus drei Optionen

Ich lebe meine künstlerische, romantische Seite in der Musik und meine seriöse Seite bei der Arbeit.

Regina Alves

ICT Business Engineer, Hamilton Services AG

Wir sind Weltmarktführer in verschiedenen Bereichen der Life-Science-Branche. Es macht Spass, bei der Entwicklung solcher Geräte mitzuarbeiten. Zudem produzieren wir sehr sinnvolle Produkte, die am Ende den Menschen zugutekommen.

Carl Meinherz

Electrical Engineer, Hamilton Bonaduz AG

Mit dem Fahrrad zur Arbeit fahren zu können und dann noch auf so einer schönen Strecke ist Lebensqualität pur.

Romana Feurer

Documentation Specialist, Hamilton Medical AG
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