Senior Quality Assurance Specialist

Sr. QA Specialist: Job Description

Abbott Core Diagnostics in Milan, Italy is looking for a

Senior Quality Assurance Specialist.

As a Senior QA Specialist, you will support the whole life cycle of our software products, either In Vitro Diagnostics (IVD) medical device software or non-medical software products.

You will closely work with R&D organization to review and approve all software deliverables, from requirements to design outputs, to test cases throughout all project milestones. After product launch, you will support the Delivery organization being responsible for the quality aspects of products customizations, installations, and servicing activities.

You will also contribute to the Quality Management System documentation maintenance, to nonconformances, corrective and preventive actions processing and to internal and external audit execution.

The ideal candidate has a demonstrable track record in the medical device sector with a focus on software processes, methods, and tools. Proficient English is a must.

Major Accountabilities

• Participate, as Quality representative, in medical and non-medical products development projects.
• Supervise quality aspects in products customizations, installation and servicing activities.
• Create / update Quality Management System (QMS) documentation in accordance with Abbott procedures and applicable regulations, ISO/IEC standards and FDA guidelines.

• 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.