Quality Assurance Specialist
2 days ago
We are seeking a highly skilled Quality Assurance Administrator to join our team at Endomag, a pioneering company in surgical guidance technology for breast cancer. As a key member of our Product Engineering and R&D teams, you will play a crucial role in ensuring the quality and compliance of our Class IIa, IIb, and Class III sterile devices.
Key Responsibilities- Drive quality excellence in product development and improvement
- Manage design control and documentation reviews, ensuring ISO 13485:2016 compliance
- Oversee quality documentation for new products, including material and sterilisation controls
- Maintain and evolve the QMS and technical files as industry standards progress
- Support release processes for subcontracted production devices
- Collaborate across departments to uphold quality standards and regulatory compliance
- Experience with ISO quality systems in the medical device sector
- Knowledge of design control, material, and sterilisation compatibility processes
- Degree in physics, chemistry, engineering, or related field (preferred)
- Proficiency with eQMS systems
- Experience in managing design and change control under ISO 13485:2016
- Competitive salary up to £36,000 per annum
- 9% non-contributory pension
- Up to 10% bonus
- Private medical insurance for you and your family
- Private dental insurance
- 25 days holiday plus an annual buy scheme for an extra 5 days
- 2 volunteering days for charity work
- Structured training for career development
Endomag is a leading company in surgical guidance technology for breast cancer, with innovative solutions transforming patient care in over 600 hospitals across 40+ countries. Recently acquired by Hologic, Endomag is poised for even greater impact and growth.
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