Senior Quality Assurance Specialist

5 giorni fa


Milano, Lombardia, Italia Abbott A tempo pieno

Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Abbott. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our products and processes.

Key Responsibilities

  • Develop and maintain Quality Management System (QMS) documentation in accordance with Abbott procedures and applicable regulations, ISO/IEC standards, and FDA guidelines.
  • Participate in medical and non-medical products development projects as a quality representative.
  • Supervise quality aspects in products installation and servicing activities.
  • Participate in internal and external audits.
  • Manage non-conformances, Corrective and Preventive Actions (CAPA), and customer complaints.

Requirements

  • Minimum 3-4 years of experience in the 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 software development process, techniques, and tools.
  • Good knowledge of MS Office products.

Preferred Qualifications

  • 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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