Senior Quality Manager - Medical Devices

Senior Quality Manager – Medical Device Manufacturing
Location: Cornwall, United Kingdom
Competitive Salary + 10% bonus + Outstanding Benefits Package
Are you a quality-driven professional seeking a leadership role in a cutting-edge medical device manufacturing environment? This is your chance to make a significant impact as a Senior Quality Manager at an established global organisation.
About the Role
Based in Cornwall, you will lead a dedicated team of six skilled professionals, driving excellence in quality and compliance at a world-class production facility. Reporting to the Director of Quality in the United States, you’ll be an integral part of the global quality team, ensuring the implementation and consistent performance of quality requirements.
As the Senior Quality Manager, you’ll oversee daily operations to ensure regulatory compliance, uphold ISO 13485 and FDA QSR standards, and champion continuous improvement within the Quality Management System (QMS). You’ll set the direction, mentor your team, and foster cross-functional collaboration to achieve measurable outcomes that drive success.
Key Responsibilities:

• Act as the Management Representative for the QMS, ensuring processes are implemented, maintained, and improved.
• Ensure compliance with EU Medical Device Regulation (MDR) and other applicable regulatory requirements.
• Oversee CAPA activities, internal audits, and document control procedures.
• Establish KPIs to measure performance, identify trends, and provide actionable feedback.
• Mentor and guide your team while setting the direction for quality standards on-site.
• Collaborate with local and global stakeholders to enhance operational effectiveness.

About You:

• Qualifications: A bachelor’s degree in quality management, chemistry, biology, or a related field (an MSc in Quality Management or similar is a plus).
• Experience: 4+ years in a similar role within a regulated manufacturing environment, ideally medical devices.
• Proficient in ISO 13485 and FDA QSR standards, with internal/external audit experience.
• A natural leader and problem solver with a robust, flexible mindset and excellent communication skills.
• Tech-savvy, with proficiency in Excel and sound computer literacy.

Why Apply?

• Competitive salary reflective of your expertise.
• Outstanding benefits, including opportunities for professional growth.
• The chance to work with a dynamic team in a global organisation dedicated to improving lives through innovation.
• A location offering the perfect blend of career opportunity and the relaxed lifestyle of coastal Cornwall.

If you’re passionate about quality, compliance, and leading a high-performing team, this is the perfect opportunity for you.
How to Apply
Ready to take the next step? Submit your CV today to join a global leader in the medical device industry.

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