Local Quality Manager for Getinge Digital Health Solutions
3 weeks ago
We are seeking an experienced Local Quality Manager to support our Business Area in the Getinge Digital Health Solutions division. As a key member of our team, you will be responsible for overseeing, implementing, and continuously improving quality management systems in accordance with regulatory standards and with the Global Getinge QMS.
Key Responsibilities- Lead the development, implementation, and maintenance of 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 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.
This role involves leading key QRC projects and collaborating closely with management and our software development department. While most of our products are not classified as medical devices, knowledge of medical device regulations is essential to facilitate discussions and provide solutions in the context of a larger corporation, where the remaining products are medical devices. Additionally, a strong understanding of data privacy and information security is crucial for success in this role.
- Experience: Minimum of 5 years in a quality, regulatory, and compliance management role as well as in information security
- Skills: Strong understanding of regulatory frameworks, proficiency in developing SOPs, excellent problem-solving abilities, and strong communication skills.
- Education: A Bachelor's degree in Information Technology, further education in Quality Management, Regulatory Affairs or in Information Security.
- Certifications: ISO Lead Auditor certification or equivalent is highly desirable.
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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Copenhagen, Copenhagen, Denmark Getinge IT Solutions ApS Full timeAbout the JobAre you looking for a challenging role in quality management? We are seeking a highly skilled Local Quality Manager to join our Getinge Digital Health Solutions team.ResponsibilitiesAs a Local Quality Manager, you will be responsible for overseeing the implementation and maintenance of our quality management systems, ensuring compliance with...
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