Quality Officer

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COMPANY OVERVIEW

2San is an accelerator of innovator in home healthcare solutions, dedicated to transforming visionary concepts into accessible products for consumers worldwide. With a strong commitment to quality, we specialize in guiding products from concept to consumer, through meticulous internal processes and a team of seasoned professionals.

Our journey begins with the discovery of groundbreaking products that have the potential to revolutionize home healthcare. We search far and wide for exceptional inventions and collaborate closely with inventors to navigate regulatory requirements. Through our guidance and expertise, we ensure that innovative products meet the necessary standards for safety, effectiveness, and compliance.

Once approved by the regulatory bodies, our products seamlessly integrate into our network of retailers, reaching millions of consumers globally. By forming strategic partnerships with retailers and distribution channels, we ensure widespread accessibility to our solutions.

At the core of our mission is a dedication to empowering individuals to manage their health effectively. We strive to make cutting-edge healthcare solutions accessible to all, fostering a healthier future for everyone.

Join us as we continue to drive innovation in home healthcare and make a meaningful impact on the world of healthcare. Welcome to 2San, where innovation knows no bounds.

ROLE OVERVIEW

We are looking for a Quality Officer to join our growing global medical device Quality and Regulatory team to support with Quality Management System activities. 2San is a global distributor of medical device products falling broadly into three categories: Clean, Protect, Test. We are maintaining an ISO 9001:2015 Quality Management System, and working towards ISO 13485 certification for a sub-division of the business.

The role of the Quality Officer will be to support the development of the QMS and provide ongoing quality assurance activities such as Supplier onboarding, Training, Workflow design, Documentation, product item management, KPIs. An eQMS system (DotCompliance) is currently being implemented and this role will hold Training Coordinator permissions in the system.

The Department is lead by an SLT member within the organisation (Global Head of Quality & Regulatory), supported by local jurisdictional experts in-region, and act as a central function to coordinate and oversee Quality Assurance and Regulatory activities across the Regions.

KEY ACCOUNTABILITIES/RESPONSIBILITIES

Strategy
Support the Quality Strategy by suitable priotitisation of activities, timely response to time-critical activities, and thorough
documentation of essential evidence and key decisions within the quality management system.

Operations
. Facilitate the proper documentation of processes within the quality management system.
Ensure good documentation practices and data integrity principles throughout the organisation.
Assist with supplier management activities such as review of Questionnaires and supplier corrective actions.
Perform the role of Training Coordinator within the eQMS system.
Own the internal audit schedule
Assist with medical writing of print/copy in collaboration with your team.

Leadership
Demonstrate the quality objectives in all activities and liaison with the wider business functions

Behaviours
Resilience
Organisation
Integrity
Flexibility

KEY SKILLS & EXPERIENCE

Life Science Degree preferred
Familiarity with ISO 9001 / 13485, MDR and other global medical device legislation for quality management systems
Previous experience of a regulated environment desirable
Willingness to learn and initiative to set own tasks from central team list required
Experience of varied maturities of QMS and eQMS platforms advantageous
Application of relevant quality management system activities: CAPA, Change Control, Risk Management, Documentation
Practical experience of working with stakeholders across the business
Ability to work GMT Time zone

CAN START IMMEDIATELY