Quality Assurance Specialist

7 dni temu


Kraków, Lesser Poland Hitachi Vantara Corporation Pełny etat

About the Position:

This is a unique opportunity to join our team as a Software Validation Lead. As a key member of our quality assurance group, you will be responsible for leading and coordinating the validation process for our software applications. Your interactions with various stakeholders will ensure compliance with regulatory requirements.

Key Responsibilities:

  • Lead and coordinate the validation process for software applications.
  • Develop a Validation Strategy for applications in accordance with 21 CFR Part 11 and Annex 11 regulations.
  • Create a Validation Plan outlining scope, purpose, roles, responsibilities, system description, and risk management.
  • Perform GxP Applicability and Criticality Assessment, Functional Risk Assessment, and Audit Trail Risk Assessment.
  • Review and approve specifications for application, qualification protocols, and executed qualification protocols.
  • Author Traceability Matrix documents and Validation/Qualification Summary Reports.

Requirements:

  • At least 4-5 years of quality management work experience.
  • Knowledge of ISO 9000 series, ISO 13485 standards, and software development life cycle.
  • Experience with Software Risk Management (ISO 14971) is a plus.
  • Ability to comprehend new documents, analyze them well enough to assess value and risks, and provide timely assistance.
  • English at the upper intermediate level.

What We Offer:

As a leader in digital engineering, we offer a dynamic and inclusive work environment that fosters continuous learning and professional growth. We prioritize work-life balance by providing flexible opportunities tailored to your lifestyle.



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