Senior Quality Assurance Specialist

Major AccountabilitiesCreate / 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.EducationBachelor degree in biomedical engineering, Computer science or equivalentRequired Qualifications / ExperienceMin 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 / ExperienceKnowledge of ISO 27001 and EU regulations 2017-746 (IVDR) and 2016-679 (GDPR).SkillsAttitude to team working and open to multi-cultural environments.Communication, collaboration, and negotiation skills.
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