Job Title:Quality Specialist Contract Type:Permanent - Days Location:Shannon, Co. Clare Reports To:TBC Requirement:On-Site Job Summary We are seeking a highly skilled and motivatedQuality Specialistto join our clients 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 Key Responsibilities may include (but aren't limited to); 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 & Skills Required Qualifications: Third level qualification in natural sciences (Certificate, Diploma, Degree level) Experience in Quality and Good documentation Procedures in a highly regulated industry (pharma, medical devices, etc.)
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.
For a confidential discussion regarding this opportunity, please contact Brendan at or via email at Skills: Quality ISO FDA QMS Quality Management NCR's CAPA Benefits: Mobile phone Paid Holidays Canteen Parking VHI Pension Laya Healthcare