Job title: Quality Assurance Specialist
Location: Western Business Park, Shannon, Co. Clare
Benefits: Good salary, Healthcare, pension, opportunity to grow your career with exciting Medical Device company working on projects from concept.


Summary:
The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development, Manufacturing including secondary packaging activities and Distribution.



Responsibilities:

• Aid the 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, CAPAs and Non conformances, Training, Internal, vendor and third party audits, participate in product and process risk assessments.
  • Perform Internal Audits or Supplier audits.
  • Perform Supplier Qualification & monitoring as requested.
  • Drive continuous improvement initiatives within the QMS.
  • 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.
  • Partake in activities for design & process validation.
  • 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.

• Customer specific tasks:
• Perform assigned tasks in accordance with specified Procedures.
• Ensure protection of client confidential information in accordance with Non-Disclosure Agreements.
• Perform specific duties associated with client services as specified in client contracts/service agreements.
• Perform all tasks in compliance with company policies and procedures.
• Support Key Projects and other duties as assigned.

• 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.