Contract Type: Permanent.
Reports To: Quality Manager.
Location: 4D Western Business Park, Shannon, Co. Clare.
Job Category: Quality Assurance.
Start Date: March 2022.
Travel Required: Not foreseen. Possible external clients
The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System at PBC BioMed in order to maintain 2017/745(MDR)ISO 13485, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development, Manufacturing and distribution and secondary packaging activities.
Roles & Responsibilities
- Aid the PBC BioMed team in the development implementation and maintenance of the Quality Management System.
- Support the operation of the Quality Management System & Documentation control such as:
- Change Controls, CAPA and NCR, Employee Training, Internal and Vendor Audits, Participate in product and process risk assessments.
- Perform Internal Audits or Supplier audits as per plan.
- Perform Supplier Qualification as requested.
- Drive continuous improvement initiatives based on quality initiatives.
- Partake in Customer specific or internal quality projects.
- Perform QA Verification of activities performed in production.
- Review and update Quality System documentation (procedures, Reports) as requested.
- Take part in Notified Body Audits and Audit preparation as requested. Generate Quality Metric reports as required and assist in any other data compilation as requested.