Digital Quality Expert for ISO Compliance

1 month ago


Copenhagen, Copenhagen, Denmark Getinge IT Solutions ApS Full time
About the Role

As a key member of our Getinge Digital Health Solutions team, you will play a pivotal role in ensuring the highest standards of quality, regulatory compliance, and operational excellence across our organization.

We are seeking an experienced Digital Quality Expert to join our team in Copenhagen. The successful candidate will be responsible for overseeing, implementing, and continuously improving quality management systems in accordance with regulatory standards and the Global Getinge QMS.

Key Responsibilities:

  • Develop, implement, and maintain the QMS and ISMS in line with Getinge requirements and industry standards.
  • Oversee regulatory compliance activities, ensuring the organization and products meet all relevant standards such as ISO 9001, ISO 27001, and ISO 27701.
  • Manage internal and external audits, ensuring continuous improvement and swift resolution of quality issues.
  • Provide expert guidance to the team, aligning business processes with regulatory requirements.
  • Serve as a key contact for stakeholders, offering strategic insights into regulatory and compliance issues.
  • Collaborate with cross-functional teams to ensure organizational alignment on quality and compliance goals.

About You

To succeed in this role, you will require a strong understanding of regulatory frameworks, proficiency in developing SOPs, excellent problem-solving abilities, and strong communication skills.

Requirements:

  • Minimum of 5 years' experience in quality, regulatory, and compliance management roles, as well as information security.
  • Bachelor's degree in Information Technology or related field, with further education in Quality Management, Regulatory Affairs, or Information Security.
  • ISO Lead Auditor certification or equivalent highly desirable.

About Getinge IT Solutions ApS

Getinge provides hospitals and life science institutions with innovative products and solutions aiming to improve clinical results and optimize workflows. Our product offerings include intensive care equipment, cardiovascular procedure solutions, operating room technology, sterile reprocessing systems, and life science instruments. With over 12,000 employees worldwide and operations in more than 135 countries, we strive to make life-saving technology accessible to everyone.

Why Join Us?

We offer a collaborative and innovative environment where your contributions will help us meet the healthcare challenges of the future. As part of our global team, you will have opportunities to work on exciting projects, develop new skills, and grow professionally.



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