OBS! Ansökningsperioden för denna annonsen har
• Maintain and develop the company’s Quality Management System (QMS)
• Management representative for the QMS
• QA Review and approval of Standard Operating Procedures (SOP) and Work Instructions (WI), Design and Development Documentation, Manufacturing and Control Documentation and Product Labelling.
• Plan, perform and execute Internal QMS audit
• Coordinate Supplier Audits with production.
• Maintain and develop Archiving system for QMS and product related documents.
• Maintain and develop procedures for Complaint handling, Change Control and Corrective/preventive Actions (CAPA)
• Establish Quality objectives and Process Performance parameters for the department and strive to meet these.
• Lead effective implementation of QMS in production
• Maintain and develop Vigilance reporting and criteria, taking into account national regulations
• Plan and coordinate Vigilance investigations, vigilance reporting and Field Safety Corrective Actions
As a person you are humble, responsible, independent and committed to your work. You are thorough and structured in your work and have very good cooperation and communication skills. To succeed in the role you are targeted, with great interest in personal development and a desire to influence to achieve results. You consider change to be an exciting challenge and you contribute to the company's positive culture.
Do you want to be part of an international team dedicated to developing innovative healthcare products for a future more secure patient care? Bactiguard is in a strong expansion phase and we are experiencing an increasing interest in our unique technology for infection prevention, particularly in light of rapidly increasing antibiotic resistance. We are now looking for a Global QA Director. You will become part of a highly skilled team of a company in growth. This position is located at our newly built head offices near Karolinska University Hospital, Huddinge.
As Global QA Director you will have the overall responsibility to develop and maintain Bactiguard’s Quality Management System and you will interact with all parts of the company, in particular the two manufacturing plants in Sweden and Malaysia. You will lead a team of four QA staff and you will report directly to the COO of the company with dotted line reporting to the CEO.