Remote-first
Fully flexible hours
Dog friendly
Job Description
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 mission-driven 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 data-driven. 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.
About the role:
Okay, we’ve waffled long enough. So let’s get to the good bit: You.
Elvie has a need for a detail-oriented, passionate and dynamic individual with a desire to be an integral part of our growing Quality team. You respect rules and regulations but are not afraid to do things differently and challenge ‘business as usual’. You are able to understand the needs and challenges of the cross-functional teams that successfully support and drive products to market; from R&D and Product Development, through Operations, Manufacturing, Sales and Marketing. 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 3rd party suppliers and the different functions within the business.
You will have experience working within the Medical Device industry, in a Quality and Regulatory focused role. You are excited by the prospect of defining the gold standard for quality, design documentation and document control in a rapidly growing business.
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
New Product Development
- Partner with R&D and supporting functions to deliver new products to market in compliance with required quality requirements and processes.
- Guide the new products and improvement project teams through consistent, compliant and lean delivery according to Design Control and Risk Management processes.
- Support the development of plans, test methods, reports and other quality documentation required for the Design History Files.
- Maintain complete and compliant Design History Files in the eQMS.
Product and Process Continuous Improvement
- Support the continual improvement of Quality System processes and tools that support the product lifecycle.
- 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.
- Help drive improvements and to create a proactive and functional eQMS with a value-added approach to Quality Management Systems.
Regulatory and Compliance
- Support the development of regulatory submissions for new products and country expansions, including 510(k) and product Technical Files.
- Support CAPA, SCAR and NCR investigation and administration.
- Support the maintenance of calibration activities and records.
- Carry out internal audits when required.
Requirements
- A degree in a relevant engineering, design or science discipline (or equivalent qualification).
- Appreciation for all stakeholders involved in new product development.
- Experience in consumer and medical device product design and development.
- Developing Quality Management Systems and the ability to interpret regulations.
- Experience ensuring a high level of compliance with MDD 93/42/EEC Medical Devices Directive, MDR, 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 & statistical software such as Microsoft Office and Google suite.
Benefits
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:
- 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
- 3 additional Elvie “in it together” bank holidays for 2022
- 8 extra life leave days; getting married, moving house, menopause or just things that you can’t put a label on that matter to you
- 5=10 leave: 10 days’ additional leave on your 5th and 10th years of service!
- £100 contribution to your home working set up to spend as you see fit
- An annual personal development allowance of £200 and unlimited access to our learning and development platform, Learnerbly
- Generous parental leave policies; maternity, paternity/partner, shared & adoption
- Healthcare plans, life insurance, and an employee assistance program for you and your family
- A tax-efficient group pension scheme
- Group income protection; protect your salary if you get sick
- A free Elvie trainer for you to keep or give away when you join
- Generous employee and friends & family discounts on Elvie products
- Wellbeing support from YuLife and 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
What you can expect after you’ve applied:
A member of our recruitment team will reach out to you after they have reviewed your application. You must ensure your application is completed correctly, and we strongly encourage you to add a cover letter or note to let us know why Elvie’s the right fit for you.
We would like to get to know you through your background, attitude, experience and understand your motivation to work with us. Our interview process varies depending on the position, but it typically looks like this:
- 20-minute video call with one of our recruiters
- 30-45 minute video call with the hiring manager
- 45-60 minute video interview with the team (some positions may require you to complete a task/presentation)
- For some positions, there may be an additional interview with one of senior our leadership team
This is undoubtedly a great time to join Elvie. You’ll have a voice, make an impact, and have the opportunity to mould your role. So be ready to learn, have fun, and be inspired by our passionate, talented team — and having a sense of humor helps too. 😉
We can’t wait to hear from you!
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