Quality Engineer, Consumables

Quality Engineer, Consumables

As a Quality Engineer for Consumables at Refeyn, you will be the driving force behind the quality performance of our consumables product portfolio. Working along side with the quality department you will proactively shape, lead, and continuously improve our quality systems and practices. You will work cross-functionally to resolve complex quality challenges, ensure compliance, and embed a culture of quality across the business. This role demands initiative, influence, and strategic thinking to drive robust processes, product reliability, and customer satisfaction.

Primary Responsibilities for this role include:

• Quality Ownership: Serve as the single point of accountability for all quality-related activities for consumables products, from design through manufacturing and post-market.
• Process Leadership: Design, implement, and maintain best-in-class quality systems, procedures, and controls, help implementing GMP, ISO 9001 and eQMS and other applicable standards.
• Risk Management: Drive product and process risk assessments (FMEA, control plans), implementing preventive and corrective actions with urgency and authority.
• Continuous Improvement: Lead quality improvement projects across the consumables value stream to enhance yield, reduce defects, and strengthen process capability.
• Change & Design Control: Own and enforce quality standards for change control, design transfer, validation, and verification activities.
• Non-Conformance & CAPA: Lead investigations, root cause analyses, and CAPA to closure with speed and rigour.
• Supplier Quality: Establish and maintain quality expectations and audit processes for consumables suppliers and external manufacturing partners.
• Cross-Functional Influence: Act as a trusted quality advisor to R&D, Operations, Supply Chain, and Product Management; drive decisions that protect product integrity and customer trust.
• Metrics & Reporting: Define and monitor key quality performance indicators, reporting trends and risks to senior leadership with clarity and conviction.

We are ideally looking for someone with the following skills and experience:

• Degree in Engineering, Life Sciences, or related discipline.
• Strategic mindset with the ability to see the "big picture" while executing on the details.
• Highly self-directed, proactive, and assertive—able to set direction and drive change with minimal supervision.
• Strong decision-making skills, able to influence and challenge stakeholders constructively.
• Excellent problem-solving skills, rooted in data-driven and structured methodologies.
• Exceptional written and verbal communication, able to convey complex quality issues with impact and clarity.
• Proven experience in quality engineering roles within a regulated manufacturing environment (medical devices, diagnostics, or similar).
• Strong knowledge of GMP and ISO 9001.
• Hands-on experience with risk management tools, root cause analysis techniques, and statistical quality methods.
• Experience driving cross-functional quality improvement projects to measurable success.
• Experience working with external suppliers and contract manufacturers is highly desirable.

We know there is no such thing as the perfect candidate, so please do not feel you need to tick all the boxes to apply!

Why work for Refeyn?

• Compensation and core benefits
• We anticipate a salary between £54,000 and £60,000, for this role, depending on the candidate's experience.
• 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.
• Anonymised Hiring Practices
• Refeyn is proud to use anonymised hiring practices. Identifying information such as a candidate's name, email address, date of birth and photo will not be visible to the hiring manager when they review CVs.