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Site Quality Assurance Manager

2 mesi fa

Milano, Lombardia, Italia Abbott Laboratories A tempo pieno

Job Summary: As a Quality Assurance Manager at Abbott Laboratories, you will oversee all aspects of Quality Assurance at a site, ensuring the quality of products and the Quality System. This includes product development elements, Design Control, process improvements, critical documentation processes, ensuring compliance with regulatory standards, and a robust CAPA process. Your role will bridge technical and non-technical aspects, contributing to life-changing technology.

Key Responsibilities:

  • Provides strategic direction and tactical assistance on matters related to regulations, quality systems, and quality issues.
  • Accountable for complying with local and global Quality System requirements applicable to the product portfolio.
  • Provides diligent and fact-based communication to the Management team, peers, and quality, regulatory, and other functional team members.
  • Provides technical support and services to Engineering, Research Development, and other cross-functional groups involved in developing, launching, and maintaining products.
  • Works as a member of the local management team to develop and monitor quality objectives, appropriate Quality KPIs, and provide oversight of Quality processes.
  • Serves as the Management Representative for the Quality System.
  • Supports development of QA personnel through interaction and training to ensure personnel are informed and that business interactions and processes comply with applicable laws and regulations.
  • Exhibits professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
  • Understands and is aware of the quality consequences that may occur from the improper performance of their specific job.
  • Has awareness of defects that may occur in their area of responsibility and across the business processes of the organization, including product design, verification, and validation, manufacturing, and testing activities.

Qualifications:

  • Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering).
  • Experience in Quality Assurance, Regulatory Affairs, or Product Development.
  • Experience in the In Vitro Diagnostics and/or Medical Device industry.