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

Who You Are

We are looking for an experienced and proactive quality professional who will be responsible for leading product and supplier quality as well as actively developing and ensuring compliance to the QMS in conjunction with the Quality Systems team. You will have extensive experience managing operational quality in a similar business/industry which utilises a contract manufacturing business model and understand the intricacies of manufacturing products with overseas suppliers.

What you’ll be doing in this role

Reporting to the Head of Manufacturing, you will lead a team of multi-skilled quality engineers, supporting new product introduction, current manufacturing, in-field reliability and supplier management.

The role will involve (but not be limited to):

Product Industrialisation / Transfer to Manufacturing

• Through a team of Operations Quality Engineers, support the introduction of new products into global contract manufacturing plants alongside the Design Quality, NPD, Manufacturing and Operations teams
• Maintain oversight of part & process qualification activities
• Continually assess the product introduction process and identify opportunities to improve consistency and quality whilst optimising the available resource and reducing cost

Production Quality (Mass Production)

• Act as technical point of contact for the CM for all quality queries, tasks and activities
• Oversight of batch release inspections and associated inspection data
• Supporting the Design Quality, CI and Manufacturing team with change management and production cut-in activities

Field Quality

• Ensure field quality issues and reasons for return are thoroughly understood on a global scale and resolved in a timely manner
• Proactive, hands-on investigation and inspection of defective products/parts when required
• Oversight of CAPA/SCAR/NCR actions and investigations
  • Management of supplier and product quality issues
  • Escalation of design issues to CI team for resolution
  • Escalation of channel behaviour drivers (non-defect) to relevant departments

Supplier Management

• Lead supplier assessment and audit activities through the team of SQA Engineers (with an ability to lead third party audits when required), ensuring the Chiaro supply base is fit for purpose
• Lead and enforce Chiaro supplier management and best practice processes when working alongside contract manufacturers
• Maintain oversight of supplier performance
• Participate in regular supplier performance reviews alongside the Operations team

Management

• Ensure a team is in place to support the activities detailed above and that they hold the relevant skills and capabilities to discharge their duties effectively
• Ensure the team have sufficient direction and leadership
• Actively manage resource and resource allocation to ensure all key priorities are met
• Maintain team compliance with ISO 13485 requirements

Data Analysis

• Support the introduction of improved product quality data systems
• Lead internal reviews of monthly data sets
• Identification of issues, changes in trends and opportunities for improvement

Requirements

• Strong leader with demonstrable experience of developing people and processes
• Significant quality systems and supplier assessment auditing experience (ISO 9001 and ISO 13485 lead auditor qualifications desirable)
• Experience working in a medical device regulated manufacturing environment in compliance with ISO 13485 and ISO 14971 advantageous
• Process Excellence / Six Sigma certification or relevant experience
• Strong working knowledge of Quality tools, techniques and theories - Gage R&R studies, FAI reports, Capability studies, DFMEA, PFMEA, control plans, P-Flow, auditing techniques, SPC, RCCA/8D, 5 Why
• Knowledge of medical device product introduction and manufacturing requirements (IQ, OQ, PQ / GMP etc)
• Experience of working alongside and managing global manufacturing partners across varying time zones and cultures
• Ability to audit manufacturing plant capability and production lines
• An ability to set expectations and stay calm and positive under pressure
• Clear and concise communication
• Flexibility to travel internationally

Location: Bristol, but we're flexible as long as you're happy to come into the office 2-3 days a week.

Benefits

What are some of the perks of working at Elvie?

We're on an exceptional journey, and can offer you a truly purpose led career, with a culture built on trust, autonomy and flexibility. In addition, we'll give you:

• 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
• An annual discretionary bonus scheme
• 25 days annual leave (plus bank holidays), plus additional days to get married or move house
• £100 contribution to your home working set up, to spend as you see fit
• An annual personal development allowance of £150 & unlimited access to our learning & development platform, Learnably
• Great parental leave policies, including paid emergency childcare
• Healthcare plans, life insurance and an employee assistance programme for you and your family
• A free Elvie trainer for you to keep or give away when you join
• Generous employee / friends & family discounts on Elvie products
• Wellbeing support from YuLife & access to SmartHealth app with unlimited GP appointments for you and your family, plus various well-being initiatives throughout the year
• Lovely offices in great locations, with drinks and snacks provided, along with fun social events (when we're able to again!)

At Elvie, we believe having diverse teams in which everyone can be their authentic self is key to our success. We encourage people from all 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.

If you need any support with your application, please get in contact with us: elvie@jobs.workablemail.com or 0203 884 7223.