Quality Officer - London, United Kingdom - Entia Ltd

Entia Ltd

Verified Company

London, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Quality Officer

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.

What you'll do as a Quality Officer:

Work on products that will improve the lives of millions of people;
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;
Maintain Design History File/Device Master Record/Technical File for each device;
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;

You have experience in:

3+ years in the Medical device industry, preferably 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 an agile startup environment

Ideally, you'll also have:

Experience managing a 21 CFR 820 compliant QMS
Extensive experience in Post Market Surveillance and other postmarket 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

Our Culture:

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 startup transforming the delivery of cancer care.
Collaborations with worldleading 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 actives
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 worldleading research institutions, healthcare providers and companies.

Interview Process: