Digital Health Solutions Quality Assurance Manager
1 month ago
We are seeking an experienced Quality Manager to join our team at Getinge Digital Health Solutions. 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:
- Develop, implement, and maintain quality management systems in line with Getinge requirements and industry standards.
- Oversee regulatory compliance activities, ensuring the organization and products meet all relevant standards.
- 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.
About You:
This role involves leading key quality projects and collaborating closely with management and our software development department. A strong understanding of regulatory frameworks, proficiency in developing SOPs, excellent problem-solving abilities, and strong communication skills are essential for success in this role.
Requirements:
- Minimum of 5 years 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.
- A 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 Us:
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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