Lead Design Quality Manager

Job Description

Life at Elvie - Meaningful work. Exceptional people

We develop extraordinary and smart technologies designed to improve the lives of women. It's a fascinating and challenging area that requires us to solve the problems that no one else has ever tackled before.

Our first product, Elvie Trainer, is an award-winning app-connected trainer that helps women strengthen their pelvic floor muscle via fun, five-minute workouts. It took the wellness industry by storm and is now available via the NHS Supply Chain. Our street cred is backed up by 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 hands-free, wearable breast pump, has received international praise, including being listed as one of the Times 100 best inventions in 2019 and ‘wearable design of the year’ at the Dezeen Awards.

Elvie has received more than 30 awards, including being named one of 15 startups “To Watch” by The Sunday Times and 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.

How do we like to work?

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’re fearless - We tackle taboos and break boundaries, requiring sensitivity and courage.
• We’re innovators - We are passionate, curious and data-driven. We are constantly learning how to work smarter, faster and better. Always embracing change and innovation.
• We’re in it together - Together, we are constantly learning, embracing change and seeking innovation, whilst having fun along the way. We stay authentic and embrace our differences.

About the role

Elvie has a need for a detail-oriented, passionate and dynamic leader with a desire to be an integral part of our growing Quality team. You shall be a confident leader with the ability to communicate across all levels of the organisation and work well in a fast-paced environment. You respect rules and regulations but are not afraid to do things differently and challenge ‘business as usual’. You are an organised and logical individual who can support the Quality team and can form a clear path through the noise when complex decisions need to be made. You shall have an expert working knowledge and experience of medical device development / design controls to be effective from the start. You will have experience working within the Medical Device industry, in a R&D Quality focused role to mentor, coach and lead the growing Design Quality team. You are excited by the prospect of defining the gold standard for quality, design documentation and document control in a rapidly growing business.

What you’ll be doing

New Product Development:

• Provide leadership to the team to maintain complete and compliant Design History Files in the eQMS.
• Work closely with our Customer Care to recover and correctly interpret insights from the field.
• Help define proposed improvements with our Engineering team and implement proposed improvements with our Manufacturing teams through consistent and robust ECO’s.
• Lead the development of regulatory submissions for new products and country expansions, including 510(k) and product Technical Files.
• Support CAPA and NCR investigation and administration.
• Carry out internal audits when required.
• Provide leadership to the new products and improvement project teams through consistent, compliant and lean delivery according to Design Control and Risk Management processes.
• Lead the ongoing development of design control processes to support our product development pipeline and help drive improvements and to create a proactive and functional eQMS with a value-added approach to Quality Management Systems.
• Work as a team player in a fast-paced environment with all stakeholders involved in new product development.
• Be an excellent communicator at all levels in the organisation.
• Have a “can do” attitude, be proactive and solutions focused.
• Ability to reviewing design documentation with a high attention to detail and risk-based approach to resolution.
• Lead the team to develop appropriate documentation including the development of plans, test methods, reports and other quality documentation required for the Design History File.

Requirements

• A degree in a relevant engineering, design or science discipline (or equivalent qualification).

• Be a natural leader with the ability to bring out the best in people.
• Appreciation for all stakeholders involved in new product development.
• Significant experience in a R&D Quality Engineering role in medical device product development.
• Developing Quality Management Systems and the ability to interpret regulations.
• Experience ensuring a high level of compliance with, MDR, IVDD, ISO 13485, 21 CFR 820, and cGMP.
• Experience in CAPA investigation and root cause analysis.
• Experience in Risk Management tools and techniques (ISO14971).
• Experience in the use of electronic Quality Management Systems and electronic Document Control.
• Experience in IEC60601-1 and IEC 60601-1-2 would be an advantage.
• Experience in 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 software such as Microsoft Office and Google suite.

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.