QMS Specialist

At Smith+Neuwe we design and manufacture technology that takes the limits off living. As a QMS Specialist you will play a critical role in ensuring our Quality Management System continues to meet global medical device regulations while evolving to support continuous improvement.

We are committed to inclusion and belonging and welcome applicants from diverse backgrounds.

Responsibilities

• Trusted quality partner within the Hull site, owning and supporting key QMS processes and helping the organisation stay audit ready at all times.
• Maintain and improve core QMS processes, interpret evolving regulatory requirements and translate them into practical, effective solutions.
• Collaborate with cross‑functional teams, support internal and external audits, and use data and root‑cause analysis to identify trends, risks and opportunities for improvement.
• Daily focus on strengthening systems that enable safe, compliant and high‑quality products for patients around the world.

Qualifications

• Solid experience within Quality Assurance in the medical device or pharmaceutical industry, with working knowledge of ISO 13485, MDR and FDA 21 CFR Part 820.
• Hands‑on experience owning or supporting key QMS processes such as CAPA, document control, change control, training, non‑conformance or audit management.
• Ability to analyse data, identify trends and apply root‑cause and continuous‑improvement methodologies to drive meaningful change.
• Clear communication and stakeholder engagement skills, enabling you to influence, train and support teams across the organisation.

Benefits

• Generous annual bonus and pension schemes
• Save As You Earn share options
• Flexible vacation and time off
• Paid holidays and paid volunteering hours
• Private health and dental plans
• Healthcare cash plans
• Income protection
• Life assurance
• Hybrid working model
• Hands‑on, team‑customised training and mentorship
• Discounts on gyms and fitness clubs, salary‑sacrifice bicycle and car schemes, and many other employee discounts

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