Are you an experienced Quality Assurance professional looking for a hands-on leadership role in a fast-paced environment? We are seeking a Quality Assurance Manager to support a leading provider of gamma sterilisation services within the medical device and healthcare industry.
About the Role:
This is a key quality leadership position within a smaller, specialist operation, offering a fantastic opportunity to make a real impact. You will be responsible for maintaining and improving quality systems, ensuring compliance with ISO 13485, ISO 9001, and 21 CFR Part 820, and leading a small quality team of two.
Key Responsibilities:
1. Oversee and maintain the Quality Management System (QMS) in compliance with medical device and sterilisation regulations.
2. Manage audits, CAPA investigations, non-conformances, and document control.
3. Act as the primary quality contact for internal and external stakeholders, including regulatory bodies and customers.
4. Support continuous improvement initiatives to enhance quality and efficiency.
5. Provide hands-on leadership to a small team, ensuring training and development.
Who We’re Looking For:
1. Experience in quality assurance within medical devices, pharmaceuticals, or sterilisation.
2. Knowledge of gamma sterilisation processes (preferred, but not essential).
3. Strong understanding of ISO 13485, ISO 9001, 21 CFR 820, and regulatory compliance, comfortable working in a smaller, fast-paced operation.
4. Some leadership or supervisory experience (doesn’t have to be extensive).
Why Apply?
1. Work in a specialist industry with a growing demand for sterilisation services.
2. Make a direct impact in a key quality leadership role.
3. Join a tight-knit team where your contributions are highly valued.
Interested? Apply today or contact us for more details.
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