Major Accountabilities
* Create / update Quality Management System (QMS) documentation in accordance with Abbott procedures and applicable regulations, ISO/IEC standards and FDA guidelines.
* Participate, as Quality representative, in medical and non-medical products development projects.
* Supervise quality aspects in products installation and servicing activities.
* Participate in internal / external audits.
* Manage non-conformances, Corrective and Preventive Actions (CAPA), customer complaints.
Education
Bachelor degree in biomedical engineering, Computer science or equivalent
Required Qualifications / Experience
* Min 3 - 4 years of experience in Medical Device business sector.
* Knowledge of ISO 9001, ISO 13485, ISO14971, IEC 62304, FDA 21 CFR Part 820 and related FDA guidelines.
* Fluent English oral and written.
* Knowledge of SW development process, techniques, tools.
* Good knowledge of MS Office products.
Preferred Qualifications / Experience
* Knowledge of ISO 27001 and EU regulations 2017-746 (IVDR) and 2016-679 (GDPR).
Skills
* Attitude to team working and open to multi-cultural environments.
* Communication, collaboration, and negotiation skills.
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