Remote-first – London / Bristol Office Optional
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.
As a Senior Quality Systems Specialist, your role sits within the Quality team. You shall play a pivotal role and assist the Lead Quality Systems Manager in support of the continuous development of the Quality Management System (QMS) to assure it is aligned with regulatory expectation and achieve ISO 13485:2016 certification.
Location: Hybrid working; a mix of working from our London or Bristol office & working remotely
Employment type: Permanent (please note, you must have the right to work in the UK)
What you’ll be doing in this role
- 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 level in a Life Science, Engineering, Design or Science discipline (or equivalent qualification) or equivalent experience within medical device or pharmaceutical industry.
- Ideally a minimum of 3 years in medical device, pharmaceutical and or biological industry is required.
- Experience writing Standard Operating Procedures (SOPs) is required.
- Experienced and qualified in auditing, preferably in ISO 13485:2016.
- Experience ensuring a high level of compliance with MDR, ISO 13485, FDA 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.
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
- 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!
Belonging at Elvie
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.
Company benefits
Additional employee ratings
(these do not contribute to the FlexScore®)
Working at Elvie
Company employees
Gender diversity (male:female)
Office locations
Funding levels
Hiring Countries