Description
Life at Elvie – Meaningful work. Exceptional people
We develop smarter technology for women and are committed to building extraordinary products that improve women’s lives.It’s a fascinating and challenging area to be addressing as it requires all our employees to stretch themselves and solve problems that no-one’s tackled before.
Our first product, Elvie Trainer, is an award-winning app-connected trainer that helps women strengthen the pelvic floor via fun, five-minute workouts. It took the wellness industry by storm and is now available via the NHS Supply Chain. Our street cred includes more than 12 awards for innovation and design, including the prestigious Red Dot Award and an IDA Design Award.
Our second innovation: Elvie Pump, the world’s first silent wearable breast pump, has received international praise, including being listed as one of Times 100 best inventions in 2019 and ‘wearable design of the design of the year’ at the Dezeen Awards.
Elvie has received more than 30 awards, including being named as one of 15 startups “To Watch” by The Sunday Times, ranked as the 6th fastest growing business in the UK by SyndicateRoom in 2019. Tania Boler has recently been rated as the 8th most influential person shaping british technology in 2019 by Business Insider and both products have been featured in the Oscar Nominee Gift Bags. In April 2019, Elvie announced a $42 million Series B, the largest ever fundraise in Femtech.
What does it mean to work at Elvie?
We work collaboratively at the forefront of the growing Femtech industry with our innovative tech-focused products. You are surrounded by people who want to improve everything and everyone around them, and are passionate about our mission. We’re driven by the fulfilment of solving hard problems are constantly considering our users and the positive impact we can have on their health and wellbeing.
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 are mission driven and not afraid to break boundaries. We relentlessly focus on going the extra mile to solve problems
- We are fearless innovators – we are passionate, curious and data-driven. We continuously embrace change and innovation
- We are 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.
Who you are:
We are looking for a Quality Systems Manager. You are a detail-oriented, passionate and dynamic individual with a desire to lead the business on its journey to a best in class quality system. You respect rules and regulations but are not afraid to do things differently, find creative solutions, and challenge ‘business as usual’. You are organised and logical and can form a clear path through the noise when complex decisions need to be made. You can develop plans of action and communicate them with confidence to different functions within the business.
You’re a quality professional with at least 6-8 years of experience, and have been working within the Medical Device industry in a Quality and Regulatory focused role. Previously experience of developing, implementing and running a ISO13485 quality management system is highly desirable. You are excited by the prospect of defining the gold standard for quality systems, design documentation and document control in a rapidly growing business.
The Day to Day of the role:
Quality Management System:
- Responsible for the day to day management and continuous improvement of the QMS in accordance with FDA CFR 820 and ISO 13485/2016
- Manage the creation of a proactive and functional eQMS with a value-added approach.
- Activity and resource planning: work out what needs to be done, by who and when.
- Coach and mentor the organisation on Quality Management Systems
- Develop, monitor and manage QMS key performance indicators to ensure continued compliance.
Product and Process Support:
- Work closely with our Customer Care to recover and correctly interpret insights from the field
- Manage the Document Management, Change Control and employee QMS Training to support day to day business.
- Day to day administration of the general requirements of the QMS
Set the Gold Standard:
- Support NPI, CAPA, SCAR and NCR investigation and administration
- Maintenance of calibration activities and records
- Carry out internal and external audits when required
Requirements
What we need from you:
- You’re a quality professional with at least 6-8 years of experience, and have been working within a highly regulated environment. Medical device industry experience would be a benefit
- Experience developing and implementing Quality Management Systems and the ability to interpret regulations.
- Experience in implementing and managing an eQMS / eDMS
- Experience ensuring a high level of compliance with MDD 93/42/EEC Medical Devices Directive, MDR, ISO 13485, 21 CFR 820, and cGMP
- A degree in a relevant engineering, design or science discipline (or equivalent qualification)
- Appreciation for all stakeholders involved in Quality Management Systems
- Experience in consumer or medical products design and manufacture would be of benefit
- Experience in CAPA investigation and root cause analysis
- Knowledge of Risk Analysis ISO 14971/2012 and IEC60601/1 would be an advantage
- Experience auditing to ISO 9001 or ISO 13485 would be an advantage
- Able to review and understand hardware, firmware and software requirements and specifications
- Must be familiar with commonly used productivity as well as eQMS software
Note: you must have the right to work in the UK to apply for this role
Benefits
Why you should join us
Elvie is at the crest of a wave! Founded by women’s health expert Tania Boler and tech entrepreneur Alex Asseily, Elvie is a collection of bright and motivated team members working across the business to shape the emerging femtech industry.
We are all passionate about creating disruptive products that address the challenges that matter most to women and dismantling the taboo around women’s bodies. Here, you can be part of a business and brand that has a positive and meaningful impact on the world, all while learning a great deal and having fun.
What are some of the perks of working at Elvie?
We are looking after you. As well as the chance to develop products with real work impact and working with dedicated and passionate colleagues, our benefits have flexibility and wellbeing in mind with:
- Great work environment – regular company socials, free daily snacks
- Flexible work environment built on trust and autonomy
- Enjoy employee / friends & family discounts on Elvie products
- Generous employee referral program
- Cycle Scheme & Tech Scheme
- A tax-efficient group pension scheme with SmartPension
- Life Insurance with Yulife
- Medical, Dental & Optical cash-plan with WPA
- Employee Assistance Program for you and your family
- YuLife Well-being app & access to SmartHealth app with unlimited GP appointments for you and your family, plus various well-being initiatives throughout the year