Company Overview
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.
Position Summary
The Quality Systems & Compliance Specialist is a global subject matter expert for all elements of the Quality Management System, including eQMS tools.
They execute and maintain the LifeScan global QMS, administrate eQMS tools, support the internal audit programme and external regulatory audits.
They support the QSC Team Leader and QSC Manager in execution of compliance activities to achieve and maintain relevant QMS certifications.
Major Duties & Responsibilities
* 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.
* Ensures QMS is compliant with all applicable regulations and standards; maintains a state of inspection readiness.
* Maintains personal expertise of applicable regulations and standards and relevant state of the art developments in QMS practices within the medical devices industry.
* Has thorough working knowledge of process criteria and applicable regulations and understand business impact of decisions and actions.
* Assesses current quality systems and recommends improvements to enhance quality/compliance and increase efficiency (e.g., reduce cycle time, increase right first time etc.)
* Use statistical methods and quality tools to continuously improve process capability.
* Supports preparation for, and participates in, external audits.
* Conducts internal audits and supplier audits as required.
Analyze data, prepare reports, and present to management forums as required.
Key Experience Requirements
* Experience with administrating & trouble shooting regulated QMS IT applications.
* Understands and has experience of Computer System Validation and 21 CFR part 11 requirements.
Role Specific Competencies:
* Working knowledge of quality management system processes and GMPs (ISO 13485 / 21 CFR Part 820) desirable
* External audit experience desirable (Notified Body, FDA etc.)
* Lead auditor qualification (ISO 9001/ ISO 13485 or equivalent) desirable
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