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We are looking for Head of Quality Management in Karlskoga, Sweden, an international company, world leader in innovative solutions. In the role as Head of Quality Management you will be responsible to lead the Quality team for Quality Engineering, Quality Assurance and Quality Control, a group of approximately 10 employees. The role entails harmonizing standards and aligning with the Global Management system. You will ensure that all products and services meet company standards, customer requirements and legal requirements. The position is based in Karlskoga, Sweden and reports to the Head Global Implant Systems QM in Yorba Linda, USA.
• Management representative for the site according to System Regulation ISO 13485, 14971 and 21 CFR 820
• Accountable for the budget of the Quality Management local site
• Develop, implement, and maintain the Quality Management System in accordance with FDA’s Quality
• Execution of the “quality related processes” from product development, launch of products, manufacturing, distribution and product follow up
• Investigations on site quality issues, follow-up CAPA’s, support Post Market Surveillance and adverse event handling
• Perform the local Management Reviews and head other quality-relevant meetings
• Guide operations towards decided quality objectives and monitor the performance of the local Quality system and report it to the global Quality organization
• Train and educate the local organization in the Quality Management System and the process approach
• Be a Member of the global internal audit team and conduct internal audits on- and offsite
• Host and attend any quality assessments by authorities’ inspectors visiting the site
• Close cooperation with the Global Quality Team
• Degree of Master of Science in Engineering or technical background with several years of professional experience in Quality Management in the Medical Device Industry
• Documented Leadership experience and excellent organizational skills required
• Excellent written and verbal communication skills in Swedish and English
• Must be proficient with MS Office applications and advantage with knowledge in SAP
• High level of interpersonal skills
• Highly dedicated for drive for change with ability to analyze and troubleshoot
• Excellent skills of building successfully teams by coaching and develop others
• Must have the ability to strive for continuous improvement and support the development of global standards and processes for Quality Management
Nobel Biocare is the world leader in innovative restorative and esthetic dental solutions, providing dental professionals with state-of-the-art evidence-based tooth-to-root solutions, including dental implants, all-ceramic crowns, bridges and laminates, guided surgery planning, scanners and biomaterials. The company is listed on the Swiss Stock Market and has revolutionized the dental market with innovative products and procedures since it has been founded more than 40 years ago.
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.
Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.
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