To strengthen our Northern Europe team, we are looking for a
  The Quality Manager will provide expertise on regulatory requirements and applicable standards and regulations for Quality Management system, Good Documentation Practice, and the assessment of new or changed regulatory requirements and manage their implementation within the Northern Europe region. This position will report to the Regional Director Northern Europe. Based in Copenhagen, Stockholm or remote.
 

• You are the quality system responsible person for distribution processes in Northern Europe
• Ensure quality system and regulatory compliance with applicable regulations. (e. g. ISO 13485 / ISO 9001, MDR)
• Ensure compliance with all directives, laws and standards, especially country-specific requirements including, but not limited to, for example receiving, shipping and storage of products
• Work collaboratively with the German KARL STORZ headquarters and ensure that all Northern Europe subsidiaries comply with the given KARL STORZ quality system standards
• Ensure compliant customer complaint handling and vigilance processes with the given KARL STORZ standards and country-specific requirements
• Work collaboratively with the local stakeholders to support business goals and business critical processes
• Support process definition and implementation within the company, ensuring consistency and effi-ciency of the processes within subsidiaries in the region
• Generate and review SOPs, forms and reports and other forms of documentation as required
• Support creation of quality agreements
• Responsibility for audit management (internal and external)
• Provide training for regional KARL STORZ staff on quality relevant processes
• Consult and support of KARL STORZ subsidiaries and selected dealers in general QM topics

 

• Academic degree in medical science, technical subject or equivalent
• Proven professional experience (>3 years) in quality management in a regulated industry
• Experience in accompanying internal/external audits
• Business fluent in English skills
• Effective communication skills
• Self-motivated, proactive, with a “Can do” attitude

  If you are interested in this position, then we look forward to hearing from you. Please submit your complete application documents (cover letter, CV, qualifications, and references) online via our career portal. In case of questions, please do not hesitate to email Michelle Cheng-Christensen at Michelle.Cheng-Christensen[AT]karlstorz.com.
 
We welcome your application.