Head of Quality Assurance

Job Description:

The Head of Quality Assurance is the Management representative for the production site Nobel Biocare in Karsloga, Sweden. The incumbent participates and manage personal in the development and implementation of the QMS according to current FDA regulation, ISO13485 standard and other applicable Quality system regulations. The Head of Quaity Assurance is responsible for managing audits, to secure investigations of non-conformances, implementation of corrective and preventive actions as well as lead and develop the processes with in Quality. The holder of the position ensures that employees in the area of responsibility has sufficient competence and oversee the development required to support continuous improvement progress.
 

• Lead and develop the Quality department consisting of QC and QA
• Ensure continuous improvement in Quality area
• Monitor and report KPI’s for the site as well as global KPI’s within Quality and report locally and globally
• Manage and host audits on site including audit responses
• Manage quality issues and secure cross functional involvement
• Secure management of site specific CAPA’s
• Responsible for site Management Review
• Accountable for budget
• Secure complaint handling on site

Job Requirements:

• Experience from production and process industry
• B.Sc, M.Sc in Engineering or equivalent work experience in relevant area
• Proven track record of people management
• Experience with ISO 13485 and GMP
• Change management
• Knowledge on CI
• Knowledge on systematic problem solving tools like 8D
• Experience on driving Quality culture
• Demonstrated fluency in Swedish and English, both spoken and written
• Excellent communication skills
• Excellent organizational skills
• More than 5 years of experience in regulated process industry
• Professional experience in Quality Management in industries such as medical device, pharmaceutical or food industry
• Experience in Management positions

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Operating Company:

Nobel Biocare

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