Senior Quality Engineer
Who we are
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 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 a Red Dot Award), and in 2017 alone Elvie was recognized as one of the UK’s top 33 start-ups by TechCityUK, named one of the 15 start-ups “To Watch” by The Sunday Times and ranked as the 13th fastest growing business in the UK by SyndicateRoom.
We recently launched our second innovation: Elvie Pump, the world’s first silent wearable breast pump, which is making it possible for mothers to pump anytime, anywhere. Elvie Pump received international praise following its unveiling on the catwalk at London Fashion Week and our playful launch video (featuring cows and a custom soundtrack - go check it out) set the headlines alight!
We are looking for an intelligent full-time Senior Quality Engineer or Quality Manager to join our multi-award winning R&D team.
Who you are
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 Product Development industry for around 6 years, a significant portion of this being within the Quality function. You are excited by the prospect of defining the gold standard for quality, design documentation and document control in a rapidly growing business. You are practical and hands-on and lead by example.
What you will do:
Set the gold standard
- Ensure our products reflect the quality customers expect of a premium brand regarding out-of-box experience, product performance, product reliability and customer service. Set the quality standard for our existing and future products.
- Conduct product audits on site in our warehouses and factories.
- Manage our existing quality management systems & develop them for future needs. Plan for growth, scope out and implement best working practice.
Product and Process Improvement
- Get hands-on with our current products. Develop metrics to establish if our products are meeting and exceeding user expectations.
- Work closely with our Customer Care and Data Science teams to recover and correctly interpret insights from the field.
- Define Test Plans, Test Methods, SOPs and RCCA’s. Conduct and/or oversee test activity and reporting.
- Manage defect and bug reporting (software) across the product team.
- Help to define proposed improvements with our Engineering team and implement proposed improvements with our Manufacturing teams through ECO’s.
Regulation and Compliance
- Ensure our current and future products are compliant with regulations in current and new markets.
- Manage regulatory testing and reporting.
- Keep up to date with the regulatory guidance for post market surveillance and reporting requirements for medical devices.
- 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 6 years in the product development industry.
- Knowledgeable in the field of Quality Assurance and its application, including various quality tool and techniques such as Fishbone, Pareto, Cause-and-Effect.
- Knowledge in FDA CRFs/MDR/ISO13485 would be of benefit?
- Working knowledge of c.GMP/GDP would be a benefit.
- Able to review and understand hardware, firmware and software requirements and specifications.
- Able to understand part drawings, including GD&T.
- Capable of running manual and automated tests.
- Knowledge of basic statistical principles and its application is a must.
- Knowledge and practical experience with measurement equipment would be an added advantage.
- Must be familiar with commonly used productivity & statistical software such as Microsoft Office and Minitab.
- Competitive base salary plus generous 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
- Dice Night (Beer Tuesdays!)
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