LifeScan is a global leader in blood glucose monitoring and digital health technology and has a vision to create a world without limits for people with diabetes and related conditions. More than 20 million people and their caregivers around the world count on LifeScan’s OneTouch products to manage their diabetes. The team has an unwavering commitment to quality in the development of agile products and digital platforms defined by simplicity, accuracy, and trust to enable knowledge, wellness, and health of individuals. At LifeScan we believe our talented and passionate team is what makes us special.

The Quality Systems & Compliance Analyst supports the execution and maintainance of the LifeScan global Quality Management System by execution of tasks including administration of eQMS tools, system troubleshooting, data analytics, process improvements and providing process guidance to end users.
They support the internal audit programme, external regulatory audits and compliance activities to achieve and maintain relevant QMS certifications.
They will build knowledge and expertise in all QMS elements to become Subject Matter Experts.

 Performs quality support duties including implementation, maintenance, and execution of quality management system processes and eQMS system, including system administration activities.
 Provides ongoing support, advice, and guidance to customers on QMS processes and software tools.
 Supports quality/improvement projects.
 Supports the QSC Team ensuring QMS is compliant with all applicable regulations and standards; maintains a state of inspection readiness.
 Develops and maintains personal expertise of applicable regulations and standards and relevant state of the art developments in QMS practices within the medical devices industry.
 Develops a thorough working knowledge of process criteria and applicable regulations and understand business impact of decisions and actions.
 Recommends and supports QMS improvement initiatives to enhance quality/compliance and increase efficiency (e.g., reduce cycle time, increase right first time etc.)
 Develops an understanding of statistical methods and quality tools to continuously improve process capability.
 Supports preparation for, and participates in, external audits.
 Supports internal audits and supplier audits as required.
 Performs data analytics and data reporting to support the QSC Team as required.

 Experience working in regulated industry desirable.
 QMS IT system administration experience desirable.

 Working knowledge of quality management system processes and GMPs (ISO 13485 / 21 CFR Part 820) desirable.
 Confident communicator – both written and verbal