Digital Health Solutions Quality Manager
4 weeks ago
Getinge is seeking a Quality Manager to join our team in Copenhagen. As a Quality Manager, you will be responsible for ensuring the highest standards of quality, regulatory compliance, and operational excellence across our organization.
Key Responsibilities:
- Lead the development, implementation, and maintenance of the Quality Management System (QMS) and Information Security Management System (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 and others.
- 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 the Role:
This is a challenging and rewarding role that requires a strong understanding of regulatory frameworks, quality management systems, and information security. As a Quality Manager, you will have the opportunity to work with a global team and contribute to the development of quality management systems that meet the highest standards.
Requirements:
- Minimum of 5 years of experience in a quality, regulatory, and compliance management role, as well as in information security.
- Strong understanding of regulatory frameworks, proficiency in developing SOPs, excellent problem-solving abilities, and strong communication skills.
- Bachelor's degree in Information Technology, further education in Quality Management, Regulatory Affairs, or in Information Security.
- ISO Lead Auditor certification or equivalent is highly desirable.
Why Join Getinge:
Getinge is a global company with a strong commitment to quality, innovation, and customer satisfaction. We offer a collaborative and innovative environment, where your contributions will help us meet the healthcare challenges of the future. You will have the opportunity to work with a global team and be part of a company committed to diversity, sustainability, and employee development.
We encourage flexibility, offering the option to work remotely, and provide a work-life balance that allows you to thrive both personally and professionally.
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