Job Title: Quality Assurance Specialist
Located in Western Business Park, Shannon, Co. Clare.
Benefits:
* Competitive salary
* Healthcare coverage
* Pension plan
* 25 days of holiday time per year
* Opportunity to grow your career with a leading Medical Device company
Job Summary:
The Quality Systems specialist role involves supporting the development and implementation of the Quality Management System for a Medical Device client to maintain compliance with regulatory standards including MDR (2017/745), ISO 13485, ISO 14971, ISO 9001, and FDA QSR.
Responsibilities:
1. Aid the team in developing, implementing, and maintaining the Quality Management System.
2. Support the operation of the Quality Management System and documentation control including:
1. Change Controls, CAPAs, and Non-conformances
2. Training and audits (internal, vendor, and third-party)
3. Product and process risk assessments
3. Perform Internal Audits or Supplier audits
4. Drive continuous improvement initiatives within the QMS
5. Participate in customer-specific or internal quality projects
6. Verify QA activities performed in production
7. Review and update Quality System documentation (procedures, reports) as requested
8. Contribute to design and process validation activities
9. Participate in Notified Body Audits and Audit preparation as requested
10. Generate Quality Metric reports as required
Requirements:
1. Bachelor's degree in natural sciences (or equivalent)
2. Minimum 3 years' experience in Quality and Good Documentation Practices in a highly regulated industry (pharma, medical devices)
3. Strong planning and organizational skills
4. Excellent communication (oral and written)
5. Highly motivated individual with attention to detail