Quality Specialist - Bristol, United Kingdom - Elvie

Elvie

Verified Company

Bristol, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

The position:
Quality Specialist

Life at Elvie; Meaningful work, Exceptional People

We're Elvie. We create smart products, new solutions, and a fair few taboo-busting conversations while we're at it. Founded by Tania Boler in 2013, we develop extraordinary innovations designed to improve women's lives.

It's a fascinating and challenging area that requires us to solve problems that no one else has ever tackled before.

At Elvie, you'll be surrounded by people who want to improve everything and everyone around them. People who are passionate about our mission.

People who are driven to solve problems and constantly consider the best ways to improve the health and wellbeing of women.

Find out more about life at Elvie here.

We're deeply proud of our values, which are intrinsic to the way we behave every day.

We take them seriously because we want our culture to thrive:

We make an impact: We're missiondriven and not afraid to break boundaries. We relentlessly focus on going the extra mile to solve problems.
We're fearless innovators: We are passionate, curious, and datadriven. We continuously embrace change and innovation.
We're in it together: we fail and learn fast — always as one team — and have fun along the way. We stay authentic and embrace our differences.

Did you know?
In some regions our amazing products are considered to be medical devices. This means we maintain our Medical Device quality management system in compliance with ISO 13485:2016, to support the development of our groundbreaking products

About the role:

Okay, we've waffled long enough.

So let's get to the good bit:
You.

As Quality Specialist you will be part of the Operations Quality team reporting to the Senior Supplier Quality Assurance Engineer.

We are a small team with a lot of ambition to drive improvement of our suppliers and products. Which is where we need you

This is a brand new role to join our team we are looking for a dynamic team player that is able to support both our Senior Operations Quality Engineer and Senior Supplier Quality Assurance Engineer with a variety of administrative based activities with an opportunity to learn and develop skills in both the product and supplier Quality areas of expertise.

Location:
Hybrid working; a mix of working from our Bristol office & working remotely

Employment type:
Permanent (please note, you must have the right to work in the UK)

What you'll be doing at Elvie:

Tracking and Management of Engineering change control documentation within eQMS. Key point of contact when uploading document into our eQMS
Participate and represent Operations Quality in smaller engineering change order projects.
Department lead and expert in ensuring that the eQMS system is kept up to date form an Operation Quality perspective.
Gathering data for and reporting on the department and supplier Key performance indicators.
Following up on Supplier corrective action reports, ensuring that 8D reports are completed on time and in full.
Support consumer complaint documentation and system management.
Support supplier onboarding process.
Complete supplier evaluation and reevaluation.
Complete annual traceability exercises.

Requirements:

What we are looking for:

First and foremost we want people with an authentic desire and enthusiasm to work within a social purpose led scale up organisation committed to bettering the lives of women.

Beyond that

Someone with passion for Quality.
An excellent communicator who can engage people and teams cross functionally to drive Quality improvements.
A person who is organised, accurate, loves getting into the detail with proven multitasking skills.
Working knowledge of Quality tools, techniques and theories
Capability studies, FMEA, control plans, RCCA/8D, 5 Why
Knowledge of medical device quality and manufacturing requirements (ISO 13485 and FDA CFR 21 highly desirable)
Knowledge of medical device product introduction and manufacturing requirements (IQ, OQ, PQ / GMP etc)
Process Excellence / Six Sigma certification desirable
An ability to set expectations and stay calm and positive under pressure

Benefits:

The benefits you'll get:

We're on an exceptional journey. And we can offer you a genuinely purpose-led career with a culture built on trust, autonomy, and flexibility.

In addition, we'll give you:

9 Day Fortnight for our full time employees we work 9 days every Fortnight with every other Friday as a nonworking day for you to spend as you wish
Lots of flexibility: whether it's working from home, doing the school run, or life admin, we understand that flexibility is essential, and we trust you to do the right thing for you and us
Share options: we want everyone to have a stake in our success
25 days' annual leave, plus bank holidays
8 extra life leave days; getting married, moving house, menopause or just things that you can't put a label on that