Job Title: Quality Assurance Specialist
Located at Western Business Park, Shannon, Co. Clare.
Benefits:
* Good salary
* Healthcare
* Pension
* 25 days holidays
* Opportunity to grow your career with a Medical Device company working on projects from concept.
Summary:
The Quality specialist role involves supporting the development and implementation of the Quality Management System for a Medical Device client to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements.
Responsibilities:
1. Aid the team in the development, implementation, and maintenance of the Quality Management System.
2. Support the operation of the Quality Management System & Documentation control, including Change Controls, CAPAs, and Non conformances.
3. Participate in Training, Internal, vendor, and third-party audits, as well as product and process risk assessments.
4. Perform Internal Audits or Supplier audits.
5. Drive continuous improvement initiatives within the QMS.
6. Partake in Customer-specific or internal quality projects.
7. Perform QA Verification of activities performed in production.
8. Review and update Quality System documentation (procedures, Reports) as requested.
9. Partake in activities for design & process validation.
10. Take part in Notified Body Audits and Audit preparation as requested.
11. Generate Quality Metric reports as required and assist in any other data compilation as requested.
Requirements:
* Qualifications: Third-level qualification in natural sciences (Certificate, Diploma, Degree level).
* 3+ years experience in Quality and Good Documentation Practices in a highly regulated industry (pharma, medical devices).
* Good planning and organizational skills.
* Good communication (oral and written).
* Hardworking and highly motivating individual, with good attention to detail.