Elvie is a health and lifestyle brand developing smarter technology for women. We are committed to building extraordinary products that improve the health and lives of women everywhere and at all stages of life.
Our first product, Elvie Trainer, is an award-winning app-connected Kegel trainer that helps women strengthen the pelvic floor via fun, five-minute workouts. Launched in October 2015 to great acclaim, we took the wellness industry by storm! Our street cred includes more than 12 awards for innovation and design, including the prestigious CES Innovation Award, IDA Design Award and Red Dot Award. As a business, Elvie has been recognized as one of Wired’s ‘hottest start-ups’, named as one of the 15 start-ups “To Watch” by The Sunday Times and both products have been featured in the Oscar Nominee Gift Bags.
We recently launched our second innovation: Elvie Pump, the world’s first silent wearable breast pump, which is making it possible for new mothers to pump anytime, anywhere. Elvie Pump received international praise following its unveiling on the catwalk at London Fashion Week and at the Consumer Electronics Show (CES) in Las Vegas.
In April 2019, Elvie announced a $42 million Series B led by IPGL and supported by Octopus Ventures and Impact Ventures. This represented the largest ever fundraise in femtech. This new round of financing will accelerate Elvie’s research and development efforts, as well as help grow brand awareness and distribution for Elvie Pump and Elvie Trainer across the Americas, Europe and Asia.
Elvie has a need for a detail-oriented, passionate and dynamic individual with a desire to be an integral part of our 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 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 have been working within the Medical Device industry for around 3 years, 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.
The Day to Day of the role:
Product and Process Improvement
- 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 ECO’s.
- Help drive improvements and to create a proactive and functional eQMS with a value-added approach to Quality Management Systems
Regulation and Compliance
- Vigilance reporting
- Maintenance of technical files
- Risk based approach to supplier management.
Set the Gold Standard:
- Document change control day to day.
- Day to day administration of the general requirements of the QMS.
- CAPA, SCAR and NCR investigation and administration.
- Review of design and development processes.
- Maintenance of calibration activities and records.
- Carry out internal and external audits when required.
- Supplier approval and the associated duties involved in supplier control.
What we need from you:
- 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 or medical products design and manufacture would be of benefit.
- A level of experience you might get after around 2-4 years within a highly regulated industry.
- 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.
- Knowledge of Risk Analysis ISO 14971:2012 and IEC60601-1 would be an advantage.
- Experience 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
In return we can offer:
- Competitive base salary plus bonus
- Early stage share options in a rapidly growing business
- Work with an experienced, dedicated and passionate team that share the same values and love what they do
- 25 days annual leave plus all annual holidays in the UK
- Flexible working hours - our culture is built on trust and autonomy
- The chance to develop products with real world impact
- Career progression and regular performance reviews
- Employee referral program
- Part time opportunities & childcare vouchers
- Regular company socials
- MacBook Pro
- As much tea and coffee as you can consume, plus free beer, cider, and prosecco on tap!