Quality Manager

at  ENTIA LTD

Quality Manager
Entia Ltd, Lloyds Avenue, London, UK
Permanent, Full Time
Entia is building a world where we live long and healthier lives because cancer care is personalised to us.
We’re an oncology services company supporting the delivery of more effective cancer care by reducing the occurrence and severity of treatment side effects. We use unique remote patient monitoring solutions (including the world’s first at-home blood count analyser) and ai-driven analytics to identify patients at risk of serious complications so that early interventions can be initiated. The result is more time on treatment, fewer unplanned hospitalisations and better survival outcomes. We’re working in partnership with some of the largest global oncology centres and are supporting blockbuster therapies from the likes of Pfizer.

QUALIFICATIONS:

• A relevant Bachelors degree in a scientific field
• Accredited ISO13485:2016 Lead Auditor training and/or Internal Audit training

• Work on products that will improve the lives of millions of people;
• Responsible for maintaining an ISO13485:2016 accredited QMS;
• Authoring, establishing, and monitoring the company’s quality procedures, standards and specifications;
• Working with tech and design staff to establish quality requirements from external suppliers;
• Ensuring that design, development, and manufacturing/production processes meet international and national standards;
• Monitor performance by gathering relevant data and producing statistical reports;
• Use and maintain relevant quality tools;
• Making information available to managers and other staff that builds an understanding of how to improve the business and to support an understanding of key quality and regulatory risks;
• Reviewing company practices and providing advice on changes to systems;
• Help maintain and cultivate Entia’s positive culture;
• Coordinating and conducting supplier and internal audits as needed;
• Establishing and maintaining internal employee training records/program against our QMS processes;
• Coordinate CAPA process;
• Act as Management Representative;
• Maintain Design History File/Device Master Record/Technical File for each device;
• Organise and specify regulatory requirements for both products and processes;
• Support the process of specifying regulatory requirements for products and processes.
• Liaise with and maintain a relationship with notified bodies, national regulatory bodies and any regulatory consultants;