QMS Engineer

Refeyn is the world's pioneer in mass photometry – a ground-breaking technology that weighs individual molecules and particles with light. It transforms our ability to characterise the composition, structure and dynamics of biomolecules and biomolecular complexes, nanostructures, and viral capsids.

Since being spun out of the University of Oxford in 2018, Refeyn has been developing mass photometry instruments and delivering them to customers around the world – at leading academic institutions and in biopharma. We are continuously pushing the boundaries of what mass photometry can achieve.

With headquarters in Oxford, UK as well as offices in the US, we are a growing, global company with a team of over 180 employees (and growing). In addition to achieving market success, Refeyn has attracted a high level of investment – we raised $70m in our Series B funding round in March 2022.

At Refeyn, we are fiercely proud of our talented workforce, whose creativity, tenacity and skills have enabled us to evolve into a successful, well-funded and rapidly growing company in just a few years. To achieve our ambitions – to transform analytical workflows in the life sciences, biopharma and beyond with mass photometry – we are continuing to expand our workforce.

We strive to be an outstanding place to work – by maintaining a positive and inclusive culture, offering competitive salaries and benefits, encouraging ongoing training and development, plus, of course, plenty of other perks.

Job Overview

This is an exciting opportunity for an experienced QMS Engineer to join the Quality Team. Reporting directly into the Quality Director, you will play a pivotal role in selecting and implementing an eQMS system to help drive Refeyn towards ISO9001:2015 certification (projected in 2025).  You will also participate in an internal inspection readiness program, providing support for the rest of the organisation and collaborate with internal departments to ensure any quality processes are implemented effectively. This role would suit a driven individual, with a proven track record of a successful eQMS implementation as well as SME, who can provide technical knowledge and expertise. If you like to work in a fast paced, driven environment, we’d like to hear from you !

Responsibilities

• To lead the development and implementation of an eQMS system to be ISO9001:2015 certified in 2025.
• To lead the migration of current documented processes into the eQMS
• To lead and co-ordinate all activities within the eQMS system from early stage through to full implementation across all sites within the company.
• To lead the training / roll-out plan of ISO9001:2015 across the business.
• To support the Subject Matter Experts across the business with the creation of new ISO9001:2015 complaint processes and documentation.
• To support the Quality Director for hands on supervision of the project to agreed time, cost, quality to meet deliverables and delivery strategy.
• To support the business as the eQMS Subject Matter Expert, leading the administration of the system whilst driving system improvements and development as required.
• Responsible for leading the implementation with the SMEs across the business by regular review meetings, action plans and where required escalation of risks/delays to the Quality Director.
• Responsible for ensuring the system is operational for all sites 24/7, allowing critical functionality to be maintained.
• Responsible for developing implementation plans and training for new eQMS elements.
• Responsible for ISO9001:2015 and eQMS training for new employees.

Candidate Requirements

Skills: 

• Advanced experience in ISO: 9001:2015 Quality Management Systems. (ISO13485:2016 also considered)
• Basic project management or leadership experience in implementation of new systems (or equivalent skills).
• Understanding of 'Best Practice' and how to apply 'out of the box' solutions for the business.
• Demonstrate commitment to Refeyn Core Values and behaviours.
• Be a role model for Quality across the organisation by doing things right and doing the right things.
• Comply with policies and procedures and fulfil roles and responsibilities as defined to support full compliance.
• Communicate effectively both written and verbally.
• Complete work to agreed priorities and due dates. Report to those in authority if any timelines are likely to be missed.
• Perform any other duties as requested by those in authority.
• Experience in Biotech/MedTech is desirable but not essential 

This role is based at our facility one the outskirts of Oxford (near Littlemore)

Benefits

• 25 days annual leave, excess-free private health insurance, critical illness cover and income protection, up to 7% employer pension contribution, salary sacrifice nursery scheme, enhanced maternity, paternity and shared parental leave, charitable giving, development opportunities, wellbeing resources, plus on-site snacks!

Refeyn is committed to being an equal opportunities employer. We are working hard to create a safe and empowering environment for all, and firmly believe that there is great strength in building teams with different voices, experiences, perspectives and backgrounds. We welcome applicants from all sections of society to join us on our mission to transform analytical workflows using the power of light.