Abbott
vacanciesineu.com
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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