VantiveQuality Assurance Technical Services Engineer (m/f/d) - temporary
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Your role
In this role you will ensure that processes and procedures for Technical Services Operations are in compliance with regulatory requirements in Germany, Austria and Switzerland. You will actively participate in the design, implementation and/or maintenance of the quality processes in the field operations.
This role is based in Unterschleißheim near Munich (hybrid option)
What you'll be doing
Quality support to Field Service operation activities within the Cluster Central Europe, mainly for Germany, Austria and Switzerland
Local process ownership for the Technical Services Quality Systems: documentation, procedures, training, internal and external audit, CAPA and non-conformities, compliance to post marketing surveillance activities (product complaints, medical device vigilance, and Field Corrective Actions), supplier qualification, validation process (IQ, OQ, PQ protocols), change control process and risk assessment
Support and ensure compliance with field operations processes: device release, labelling, storage areas, calibration, decontamination, equipment validations and repair
Maintain a strong relationship with the local Technical Services team
Local Trainer
Quality KPIs- trending and actions
Support or lead local and/or European projects
What you'll bring
Master’s degree in electrical/electronic engineering, biomedical sciences/chemistry or equivalent degree in the technical/technology field
Minimum 1-3 years of experience in quality management in a medical device or technical service organization – quality processes related to service activity OR experience in technical service/ manufacturing environment
Quality System and Quality Assurance knowledge in operations
knowledge of ISO 9001:2015 and ISO 13485:2016
Expertise in medical device or electro-mechanical products
Ability to manage different tasks in an international environment
Effective interpersonal skills
Excellent written and oral communication skills in English and German
Have we sparked your interest?
If you like the sound of the above role, can thrive in a fast-paced working environment and are excited about working in a learning and growth culture, then we’d love to talk to you. Apply direct on our Online System.
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Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link
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