Lead Quality Engineer
Award winning start up making waves in the Femtech idustry
Life at Elvie - Meaningful work. Exceptional people
About Our Client
Elvie is at the crest of a wave! We develop smarter technology for women and are committed to building extraordinary products that improve women's lives.
Founded by women's health expert Tania Boler and tech entrepreneur Alex Asseily, Elvie is a collection of bright and motivated team members working across the business to shape the emerging femtech industry.
We are all passionate about creating disruptive products that address the challenges that matter most to women and dismantling the taboo around women's bodies. Here, you can be part of an award winning business and brand that has a positive and meaningful impact on the world, all while learning a great deal and having fun.
A recent round of new financing (Series B , so far to over $50 million) will accelerate Elvie's research and development efforts, as well as help grow brand awareness and distribution. We currently have offices in London, Shanghai and New York and are really excited about the opening of our new R&D facility in Bristol.
The Day to Day of the role:
Manage the Quality Engineering team, projects to time lines and budget:
- Activity and resource planning: work out what needs to be done, by who and when
- Coach and mentor the quality team
- 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
- 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
The Successful Applicant
We are looking for a Lead Quality Engineer.
- You are a detail-oriented, passionate and dynamic individual with a desire to lead the Quality Engineering 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, 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're a quality engineer with at least 6-8 years of experience, and have been 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.
- 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
- 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 as well as eQMS software
Note: you must have the right to work in the UK to apply for this role
What's on Offer
What are some of the perks of working at Elvie?
We are looking after you. As well as amazing colleagues and engaging work, our benefits have flexibility and wellbeing in mind.
- The chance to make a real impact in improving women's health and lives
- Working with an experienced, dedicated and passionate team that share the same values and love what they do
Career progression and regular performance reviews
- Competitive base salary, bonus linked with performance and share options in a rapidly growing business
- 25 days annual leave plus bank holidays
- Flexible working environment - our culture is built on trust and autonomy
- Well-being - we provide a growing programme with daily healthy snacks, cycle to work scheme, free preventive health check, free flu vaccination, mental health awareness, and various initiatives
- Private healthcare, pension & life insurance (coming soon)
- Regular company socials, daily snacks and as much tea and coffee that you can consume