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.

Refeyn is a values-led Company that is committed to celebrating each other’s differences and creating a dynamic, driven and diverse culture where everyone can flourish. We are proud to have been awarded Committed Status by the Inclusive Employers Standard in 2024 and are working hard to create a safe and empowering environment for all.

We firmly believe that there is great strength in building teams with different voices, experiences, perspectives, and backgrounds so that we can continue to share the team workload and enable our customers to succeed, and we welcome applicants from all sections of society to join us on our mission to transform analytical workflows using the power of light.

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 on the outskirts of Oxford (near Littlemore)

Why work for Refeyn?

Core benefits include:

• 25 days annual leave per year in addition to bank holidays
• Up to 7% employer matched pension contribution
• Private health insurance from day one plus critical illness cover, income protection and life insurance
• Give as You Earn and Cycle to Work salary sacrifice schemes.

Family Friendly Benefits

Refeyn offers the Enjoy Benefits Nursery Scheme to employees after 3 months, and new parents can benefit from up to 17 weeks fully paid maternity, adoption and shared parental leave, 4 weeks fully paid paternity leave, plus an annual allowance for emergency childcare.

Supporting your Development

All employees receive access to LinkedIn Learning which offers thousands of courses to support their personal and professional development. We also run frequent training sessions on both hard and soft skills.

Creating an Engaging Culture

Refeyn supports hybrid working where the role allows and offers flexible start and finish times. We also have a subsidised weekly lunch for onsite employees and a vibrant social calendar which includes holiday parties and midsummer festivals plus an annual team budget for managers to plan team-building activities.

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.