Quality Assurance Specialist
The successful candidate will be responsible for leading and supporting a broad range of quality systems activities. This includes implementing, maintaining, and improving the Quality Management System (QMS).
Maintaining strong housekeeping and compliance with health & safety policies is also a key aspect of this role.
* Key responsibilities include implementing and maintaining the QMS, developing quality agreements with suppliers, monitoring supplier performance, investigating non-conforming materials, and supporting internal and supplier audits.
* Additionally, the successful candidate will review and approve SOPs and manufacturing documentation.
Qualifications and Experience
* A Bachelor of Science degree in a relevant field such as science, engineering, or quality assurance is required.
* The ideal candidate will also possess a Lead Auditor qualification.
* Minimum 2 years' experience in a quality role is essential.
Regulatory Compliance
* Familiarity with FDA 21 CFR 820, ISO 13485, IVDD 98/79/EC, and IVDR (EU) 2017/746 regulatory standards is necessary.