Job Description 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:
Oversee and maintain the Quality Management System (QMS) in compliance with medical device and sterilisation regulations
Manage audits, CAPA investigations, non conformances, and document control
Act as the primary quality contact for internal and external stakeholders, including regulatory bodies and customers
Support continuous improvement initiatives to enhance quality and efficiency
Provide hands on leadership to a small team, ensuring training and development
Who We’re Looking For:
Experience in quality assurance within medical devices, pharmaceuticals, or sterilisation
Knowledge of gamma sterilisation processes (pre...