Senior Quality Assurance Specialist

Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living!

We believe that through innovation, development and supporting our customers and patients we can help others achieve a Life Unlimited. Long before any of this is possible, we have to go through many steps that will validate and verify our products.

Quality Assurance plays a vital part in the process! Ensuring our products are and remain compliant to the needs of the market, and needs of patients. Our products are in 100 countries globally, and supporting this takes a huge effort.

Our Senior Quality Assurance Specialist will focus on representing and supporting the Quality and Regulatory activities, collaborating closely with our teams in EU countries to ensure compliance and timely maintenance of the Quality Management System.

What will you be doing?

• Lead the maintenance of our quality management system, ensuring seamless operations.
• Create, refine, and review quality procedures to guarantee clarity, efficiency, and regulatory compliance.
• Represent S+N during external audits, engaging with certification bodies and regulatory inspectors with confidence.
• Act as a trusted management representative for our multisite quality system, ensuring consistency and excellence.
• Bridge the gap between European and global quality standards, ensuring full alignment with regulations.
• Oversee corrective and preventative action processes—logging, investigating, monitoring progress, generating reports, and collaborating with key stakeholders to drive timely resolutions.
• Lead the non-conformance and corrective action board across EU commercial sites, ensuring swift completion of actions.
• Provide insightful monthly reports on quality and regulatory performance metrics.
• Manage our internal audit programme—conducting risk assessments, developing annual audit schedules, and spearheading effective internal audits.
• Conduct audits across satellite sites and support supplier audits, reinforcing quality across the network.
• Take the lead on training coordination, ensuring our teams are equipped with the knowledge and skills to maintain high-quality standards.

What will you need to be successful?

To be successful, you’ll need to be an experienced quality specialist with a background in ISO 9001 or ISO 13485, alongside expertise as an internal auditor and experience hosting external audits. A passion for quality management systems, a willingness to learn, and a genuine interest in driving excellence will set you apart in this role.

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/)

• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays
• Flexibility: Hybrid Work Model (For most professional roles), flexible working hours
• Training: Hands-On, Team-Customized, Mentorship
• Interesting salary and yearly bonus on top of other company advantages.

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