Senior Quality Assurance Specialist

JOB DESCRIPTION:

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.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

CRLB Core Lab

LOCATION:

Italy > Milan : Viale Edison 110, Edison Park Centre

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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