· To lead, coordinate and plan the work within the dedicated QA/QC Team.
· Evaluate and improve QA processes.
· To coach and lead the dedicated QA/QC Team in order to develop adequate competencies, efficient working methods, optimal use of resources and a stimulating working climate
· To maintain and continuously improve procedures and instructions related to area of responsibility, compliant to FDA, MDD/MDR and all applicable regulatory and corporate requirements.
· Secure CAPA Process are implemented and followed within the organization.
· Foster a philosophy of continuous improvement in the organization, including Management of Nonconformities when needed.
· Perform Quality Review of documents related to the QMS.
· Actively take part in the Change Control Process as QA representative. Member of the PCO Board.
· Actively take part in Design Transfer activities such as Purchase Approval and Production Start Process
· Bachelor’s degree in sciences
· Experience from working within QA/QC in a Medical Device Industry, preferable class III
· Experience from acting as People Manager within QA/QC,
· Experience from participate in External Audits for example Notified Body Audits
· Knowledge within ISO 13485, FDA Quality System Regulation 21 CFR Part 820
· Knowledge about EU MDR (Medical Device Regulation and EU MDD (Medical Device Directive)
· Very good English – for writing professional documents.
· Very good knowledge with Word/Excel/Power point