Quality Officer

3 months ago

London, United Kingdom Entia Ltd Full time

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 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

**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 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 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 world-leading research institutions, healthcare providers and companies.

**Interview Process**:

- 45 minute video call with the hiring manager
- 2-3 hour team interview incl presentation/task
- 15 - 30 minute call with our CEO

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