Health Quality Engineer – Cybersecurity

July 29, 2024
Reference key: es12711
Permanent
Deadline date:

Job Description

  • Negotiable
  • Permanent
  • Dublin South

Health Quality Engineer – Cybersecurity – required by growing Digital Health company in Dublin, to be responsible for the management of ISO27001 – compliant Information Security Management System. You will also be responsible for supporting certification audits, resolution of audit findings, creating and updating operating procedures.

REQUIREMENTS:

  • Master’s Degree in engineering, scientific, or technical discipline.

  • Working knowledge as Quality Engineer having contact with regulations and standards.

  • Good understanding of ISO/IEC 27001 and GDPR.

  • Considerable knowledge of information security threats and protections.

  • Excellent interpersonal, written, and verbal communication skills (English).

  • Ability to represent the company during audits.

  • Ability to work independently and effectively without supervision.

  • Shows an organization & business awareness, including customer focus.

  • Capability to solve complex problems.

  • Ability to demonstrate the process behind the thinking.

ADVANTAGEOUS:

  • Practical experience with medical device standards such as ISO 13485, ISO 14971, IEC 62304 & IEC 62366-1.
  • Practical experience with information security risk management in compliance with ISO/IEC 27005.

RESPONSIBILITIES:

  • Create and maintain information security management system procedures to support regulatory and quality compliance.
  • Monitor, analyze and improve the effectiveness of the Information Security Management System.
  • Develop corrective actions, solutions and improvements.
  • Support the execution of ISMS processes and ensure the requirements of specifications, standards and regulations are complied with.
  • Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance.
  • Collaborate with internal teams and customers to develop and implement regulatory strategies and pathways for medical devices.
  • Conduct internal audits and ensure timely follow through on resolution of related audit findings.
  • Support certifications for ISO/IEC 27001 and ISO 13485, customer and other regulatory audits.
  • Participate in the evaluation and approval of S3 Connected Health suppliers.
  • Provide quality and regulatory related trainings.