To champion a culture of quality and continuous improvement across the Vitrolife Group
Ensure all products and services consistently meet the highest regulatory standards and contribute to excellent patient outcomes
Oversee the QMS in the Genetic Services offices
Act as a consultant to the affiliates across the Vitrolife Group
Lead, coach, and develop the Vitrolife group QA team
Maintain, improve and ensure compliance to the Quality Management System (QMS)
Implementing Quality Standards across the Vitrolife Group of companies
Following and adhering to the QMS policies and procedures
Monitoring and evaluating internal processes
Root-cause analysis and CAPA management
Establish, implement, and supervise a programme of internal audits and participate in internal audits
Data analysis and tend analysis of QMS KPIs
Analysis of customer feedback and incidences
Evaluating product recalls (when required/needed)
Define, implement, review and maintain validation plans and standards for software with impact in the Quality and software as medical device
Oversee document control
Act as Management Representative for Top Management
Collaborate with other sites and global QA functions

Have earned a bacherlor´s degree from an accredited institution.
Or have earned a bacherlor´s degree or master degree in Quality assurance/leading auditor or compliance from an accredited institution.
Fluent English skills – other languages would be considered.
Previous experience in ISO 15189, CAP, CLIA, ISO 9001 checklist and inspections.
Medical devices in vitro diagnosis experience is a strong advantage (ISO 13485)

Senior QA Manager

About this role