Senior Quality Systems Specialist

Job Description

Life at Elvie - Meaningful work. Exceptional people

At Elvie, we don’t believe women's bodies are the problem. Instead, we believe the problem is that the needs of women’s bodies – and therefore, lives – have been ignored, misunderstood, and underestimated.

Founded by Tania Boler in 2013, Elvie has been improving women's lives through better – and smarter – technology ever since. We develop innovations that meet the unique needs and complexities of the female body so that women can take charge of their health across every life stage.

Our first product, Elvie Trainer, is a multi-award-winning device bringing hospital-grade pelvic floor care to the hands of women everywhere— it was even a gift in the Oscar Nominee Goody Bags! And now, we're proud to say that we're part of the NHS Supply Chain in the UK.

Our second innovation was Elvie Pump. Launched in 2019, it's the world's first silent, wearable breast pump, enabling women to pump wherever they please— even the catwalk at London Fashion Week. It’s since won numerous awards, including the Times 100 Best Inventions of 2019 and ‘Wearable Design of the Year’ at the Dezeen Awards. The initial success of our wellness tools gave us the means to expand our breastfeeding range to include Elvie Curve and Elvie Catch, both designed to give mothers total comfort and confidence.

As a business, Elvie has received more than 30 awards (including the prestigious Red Dot Design award). We’re ranked as one of the 15 startups ‘To Watch’ by The Sunday Times and Business Insider and ranked as the 13th fastest growing business in the UK by Syndicate Room. Our founder and CEO, Tania Boler, is regularly profiled in top-tier media titles, and, in 2021, Tania was named GLAMOUR’s Women of the Year: Technology Gamechanger.

In July 2021, Elvie announced an $80 million Series C funding, the number one position and biggest raise in an initial fundraising round in the femtech category.

What does it mean to work at Elvie?

You will 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 tough problems and constantly consider the best ways to improve the health and wellbeing of women.

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

About the role

What you’ll be doing

• Responsible for the development of Quality System documents including writing policies, procedures, work instructions and forms/templates in collaboration with departments and ensure adherence to them.
• Perform training on SOPs and related ISO13485:2016 clauses.
• Support on change controls to ensure changes to processes, products, systems and facilities are appropriately assessed and implemented.
• Support on NCR investigation, CAPA, Deviations and SCARs where required.
• Support the assessment and maintenance of suppliers and contract manufacturers in accordance with the QMS.
• Perform internal audits, including creating and reviewing of audit plans and reports, leading and participating in internal audits, communicating internal audit findings to appropriate personnel and working to ensuring the timely close out of actions derived from internal audit findings.
• Support Management Review process; by preparing, interpreting and concluding on the reported data.
• Support the preparation for Notified Body Quality Systems audits, the execution of those audits in either the front or back rooms, and the follow-up/close-out activities within the QMS.
• Provide process leadership, drive quality initiatives and support the continual improvement of Quality System processes and tools that support the product lifecycle. Provide support to the Quality Systems Manager.

Requirements

• Educated to degree in a Life Science, Engineering, Design or Science discipline (or equivalent qualification) or equivalent experience within medical device or pharmaceutical industry.
• Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820, and cGMP.
• Experience in CAPA investigation and root cause analysis.
• Experience in administration of an eQMS is preferred. Familiar with commonly used productivity software such as Microsoft Office and Google Suite.
• Experienced and qualified in auditing, preferably in ISO 13485:2016.
• Experience writing Standard Operating Procedures (SOPs) is required.
• A minimum of 3 years in medical device, pharmaceutical and or biological industry is required.

Benefits

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 passionate about creating disruptive products that address the challenges that matter most to women and dismantling the taboos around women’s bodies. Here, you can be part of a business and brand that has a positive and meaningful impact on the world, 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

• Flexible work environment built on trust and autonomy
• Employee / friends & family discounts on Elvie products
• Annual personal development allowance & unlimited access to our learning & development platform
• A tax-efficient group pension scheme with SmartPension
• A tax-efficient charity donation scheme
• Life Insurance with Yulife
• Medical, Dental & Optical cash-plan
• Employee Assistance Program for you and your family
• Generous employee referral program
• Cycle Scheme & Tech Scheme
• 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

At Elvie, we believe in having diverse teams in which everyone can be their authentic self is key to our success. We encourage people from underrepresented backgrounds to apply and we don't discriminate based on race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, marital status, disability or age. We are a family-friendly employer with a culture based on trust, autonomy and flexibility, and are working on making our offices wheelchair friendly and breastfeeding friendly. We do our best to accommodate part-time requests and flexible requests as much as possible. We are also a member of UK Tech Talent Charter and proudly working in partnership with myGwork and Women's tech hub.