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Quality Manager

Entia LTD

Quality Manager

Salary Not Specified

Entia LTD, City of Westminster

  • Full time
  • Permanent
  • Onsite working

Posted 1 week ago, 19 May | Get your application in now before you miss out!

Closing date: Closing date not specified

job Ref: e2ed20cdccdc417c934b1afb98cf52b5

Full Job Description

  • 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, At Entia we take pride in our unique culture. At the core of our culture sits our values.

  • Making a difference

  • Community

  • Support and Balance

  • Knowledge and Growth


    • Our values enable us to:
  • Regularly use feedback to grow.

  • Streamline decision making and ensuring we have focused goals

  • Acknowledge and fix our mistakes without fear

  • Celebrate more together as we work towards our mission


    • What we can offer:
  • A fun and collaborative environment where you get to join a growing start-up transforming the delivery of cancer care.

  • Collaborations with world-leading research institutions, healthcare providers and companies.

  • We give you the tools and the tech you need to get you going

  • Annual company trip as well as regular company events, hack days and social activities

  • 38 Days Holiday (Inclusive of Bank Holidays)

  • A flexible work environment - our culture is built on trust.

  • Perks and benefits including corp discounts, cycle to work, pension, and personal support including mental health and financial advice.

  • Monthly training budget

  • Professional development and career progression - we want you to achieve your greatest potential here.

  • Collaborations with world-leading research institutions, healthcare providers and companies.

    5+ years in the Medical device industry, namely IVDs and its associated quality and regulatory requirements.

  • Experience working under ISO13485:2016

  • Experience working with technical standards related to product development

  • Experience working with UKCA/CE marking and IVDR regulation transition

  • Experience working in a startup and agile project environment

  • Experience in 510k submissions to the FDA


    • Ideally, you'll also have:
  • Experience managing a 21 CFR 820 compliant QMS

  • Extensive experience in Post Market Surveillance and other post-market processes

  • Experience in labeling requirements for different territories


    • Qualifications:
  • A relevant Bachelors degree in a scientific field

  • Accredited ISO13485:2016 Lead Auditor training and/or Internal Audit training


    • You are:
  • Motivated

  • A genuine believer in diversity, fairness, and inclusion

  • Ability to work individually and as part of a team

  • Good communicator

  • Happy to work with different software systems

  • Adaptable/Flexible in your work approach

  • Enthusiastic to learn and curious about the world around you

    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.