Quality Specialist
CREGG is seeking a highly skilled and motivated Quality Specialist to join our client's dynamic team in Shannon. In this role, you will support and enhance the Quality Management System, ensuring compliance with ISO and FDA QSR standards.
Your attention to detail, technical expertise, and collaborative approach will drive continuous improvement and uphold the highest quality standards in medical device design, manufacturing, and distribution.
Main Responsibilities
* Support the development, implementation, and maintenance of the Quality Management System (QMS).
* Manage quality documentation, including Change Controls, CAPA, NCRs, and Employee Training records.
* Conduct Internal and Supplier Audits as per plan and assist with Supplier Qualification.
* Participate in product and process risk assessments and drive continuous improvement initiatives.
* Perform QA verification of production activities and review/update quality documentation.
* Assist in Notified Body Audits, audit preparation, and generation of Quality Metric reports.
* Handle customer-specific tasks per service agreements, ensuring confidentiality and compliance with procedures.
* Support key quality projects and adapt to dynamic priorities as needed.
Qualifications and Skills
* Required Qualifications: Third level qualification in natural sciences (Certificate, Diploma, Degree level)
* Experience: Experience in Quality and Good documentation Procedures in a highly regulated industry (pharma, medical devices, etc.)
* Skills: Good planning and organisational skills. Good communication (oral and written). Hardworking and highly motivating individual, with good attention to detail. Appropriate computer skills - MS Office. Ability to work both independently and as part of a team. Ability to work in a dynamic environment, with changing priorities.
Benefits
* Flexitime
* Paid Holidays
* Parking
* Pension
* Laya Healthcare
* Laptop