QA Specialist - Dublin - ref. n41786415

We are seeking a Quality Assurance Specialist to join our clients team and help ensure the quality, safety, and regulatory compliance of their medical devices. In this role, you'll play a critical part in maintaining and improving their Quality Management System (QMS), supporting product lifecycle activities, overseeing batch release processes and ensuring adherence to applicable standards and regulations.

Key Responsibilities:

• Support the implementation and maintenance of the Quality Management System
• Experience in reviewing and approving batch documentation for batch release in compliance with applicable regulatory and quality standards.
• Providing GMP/GDP guidance and training to CSO Logistics
• Collaborating with cross-functional teams to ensure GMP and regulatory compliance.
• Review and maintain Device Master Records (DMRs), Device History Records (DHRs), and related quality documentation.
• Participate in the investigation and resolution of quality issues, non-conformances, and customer complaints.
• Assist in the development and execution of Corrective and Preventive Actions (CAPAs).
• Support internal and external audits, including preparation, response, and follow-up.
• Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
• Provide QA oversight for manufacturing, packaging, labeling, and distribution processes.
• Contribute to the development and review of Standard Operating Procedures (SOPs), work instructions, and other controlled documents.
• Maintain quality records and ensure proper documentation practices are followed.

Qualifications:

• Bachelor's degree in a science, engineering or related discipline
• 3+ years of experience in a Quality Assurance role within the medical device or related regulated industry.
• Effective communication and interpersonal skills.
• Ability to manage multiple priorities and work collaboratively in a team environment.
• Experience with QMS software is a plus.