Quality Systems Coordinator / Document Controller

Life at Elvie – Meaningful work. Exceptional people

We develop extraordinary and smart technologies designed to improve the lives of women. It’s a fascinating and challenging area that requires us to solve the problems that no one else has ever tackled before.

Our first product, Elvie Trainer, is an award-winning app-connected trainer that helps women strengthen their pelvic floor muscle via fun, five-minute workouts. It took the wellness industry by storm and is now available via the NHS Supply Chain. Our street cred is backed up by more than 12 awards for innovation and design, including the prestigious Red Dot Award and an IDA Design Award.

Our second innovation: Elvie Pump, the world’s first silent hands-free, wearable breast pump, has received international praise, including being listed as one of the Times 100 best inventions in 2019 and ‘Best of the Best’ at the Red Dot Awards 2020.

Our 3rd & 4th innovation: Elvie Catch and Elvie Curve launched on 7th October 2020. Elvie Curve uses natural suction to gently express milk during let-down while feeding or pumping from the other breast. It is small, compact, and securely worn in-bra. Elvie Catch, “Stops your leaks, not your day” is a set of two breast milk collection cups with slip-proof silicone skirts designed for total comfort and confidence. Discreet and fuss-free.

Elvie has received more than 30 awards, including being named one of 15 startups “To Watch” by The Sunday Times and ranked as the 6th fastest growing business in the UK by SyndicateRoom in 2019. Tania Boler has recently been rated as the 8th most influential person shaping British technology in 2019 by Business Insider and both products have been featured in the Oscar Nominee Gift Bags. In April 2019, Elvie announced a $42 million Series B, the largest ever fundraise in Femtech.

How do we like to work?

You will 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 tough problems and constantly consider the best ways to improve the health and wellbeing of women.

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’re fearless – We tackle taboos and break boundaries, requiring sensitivity and courage.
• We’re innovators – We are passionate, curious and data-driven. We are constantly learning how to work smarter, faster and better. Always embracing change and innovation.
• We’re in it together – Together, we are constantly learning, embracing change and seeking innovation, whilst having fun along the way. We stay authentic and embrace our differences.

About the role

Elvie has a need for a detail-oriented, passionate and dynamic individual with a desire to be an integral part of our growing 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 support and drive products to market; from R&D and Product Development, through Operations, Manufacturing, Sales and Marketing. You are organised and logical. You can communicate with confidence to all the different functions within the business.

You will have experience 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 and document control in a rapidly growing business.

This is a junior role as document controller within the Quality team, primarily focused on document administration and control, providing document creation support in Microsoft Word to ensure all documents are formatted to company procedures by assisting the document owner with reformatting where required and uploading.

What you’ll be doing

• Act as System Administrator for the electronic Quality Management System (EQMS), identifying improvements and controlled changes to the system in compliance with required change management processes.
• Assign licenses to new users and train new users on the EQMS in compliance with required quality processes. Present induction training sessions to new starters. Provide support to users when navigating the system.
• Be responsible for training records within the EQMS and maintain training packages for departments in compliance with required quality processes. Review status weekly and issue status reports weekly to managers. Create training records for training events held.
• Monitor progress of items in the EQMS and their progress through change control in compliance with required quality requirements and processes. Issue status reports weekly to managers. Support departments on document amendments in change control system and escalate where required. Update Standard Operating Procedures, where appropriate, in compliance with required quality requirements and processes
• Monitor progress of quality systems such as non-conformance and CAPA within the EQMS in compliance with required quality requirements and processes. Issue status reports weekly to managers. Support users on CAPA, SCAR and NCR administration.
• Support the data collection from the EQMS for reporting on Quality Objectives and KPI’s and support collation of data for Management Review.
• Support the monitoring and maintenance of calibration activities and records in compliance with required quality requirements and processes.
• Support the completion of quality documentation required for the Design History Files. Maintain complete and compliant Design History Files in the EQMS.
• Support the continual improvement of Quality System processes and tools that support the product lifecycle.
• Help drive improvements and to create a proactive and functional EQMS with a value-added approach to Quality Management Systems. Provide support to the Quality Systems Manager.