Flexa
Elvie • Bristol, United Kingdom

Senior Quality Systems Specialist

Employment type:  Full time

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

9-day fortnight
25 days annual leave + bank holidays
Open to part-time employees
Enhanced maternity leave
Charity donation scheme
Dog friendly office
Employee discounts
Enhanced sick pay
Fully stocked snack cupboard
Adoption leave
Enhanced paternity leave
L&D budget
Shared parental leave
Open to job sharing
Cycle to work scheme
Personal development budgets
Share options
Teambuilding days
Annual bonus
Volunteer days
We want to look 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
Great work environment - regular company socials, free daily snacks
Flexible work environment built on trust and autonomy
Enjoy 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 with WPA
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
Location
98%
Employees are very happy with their working location freedom
Hours
94%
Employees are very happy with the flexibility in the hours they work
Benefits
82%
Employees are very happy with the benefits their company offers
Work-life balance
80%
Employees feel that they can switch off quite easily from work
Role modelling
90%
Employees feel that flexible working is part of the culture
Autonomy
90%
Employees feel they have complete autonomy over getting their work done

Additional employee ratings
(these do not contribute to the FlexScore®)

Diversity
67%
Employees feel that the diversity is good and there are continued efforts to improve it
Inclusion
81%
Employees feel like the company culture is brilliantly inclusive and equitable
Culture
86%
Employees feel like it is a really great environment to work in
Mission
91%
Employees feel very excited about and aligned with the company mission
Salary
61%
Employees feel that their salary is good and matches the value they bring

Working at Elvie

Company employees

225

Gender diversity (male:female)

66:31

Office locations

Bristol, London, US Remote

Funding levels

$80mil

Hiring Countries

United Kingdom
United States

Awards & Achievements

Most flexible companies

Most flexible companies

Flexa100 2024
2nd – Consumer Goods

2nd – Consumer Goods

Industry awards 2023
Most flexible companies

Most flexible companies

Flexa100 2023
3rd – Retail & Ecommerce

3rd – Retail & Ecommerce

Industry awards 2022