We are seeking a Quality Assurance Specialist to join a leading Medical Device Company in Cork. This is a fantastic opportunity for an experienced QA professional to work in a high-impact, compliance-driven environment and play a pivotal role in ensuring product quality throughout the lifecycle. This is a 18 month hourly rate contract position.
Key Responsibilities:
- Responsible for ensuring compliance with all aspects of Quality inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
- Responsible for review and approval of the following types of documents: Failure investigations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP's), GxP documents & Change control documents
- Provide expert input and guidance during Change Control and Deviation Review Boards.
- Management of Quality Risk Management (QRM) processes, including integration of QRM principles within quality frameworks.
- Maintain and enhance the Quality Management Review process and ensure alignment with corporate policies.
- Monitor regulatory updates and ensure that the site quality systems remain compliant and inspection-ready.
- Drive sustained compliance initiatives, including self-inspections, internal audits, and continuous improvement activities.
- Develop and manage Quality Agreements relevant to the specialist area.
Qualification & Experience:
- Degree in Science, Engineering, or related discipline.
- A minimum of 3+ years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Strong knowledge of GMP standards and regulatory requirements
- Demonstrates advanced working knowledge of QA systems principles, methods, QA concepts, industry practices and standards
- Demonstrates audit and investigation skills, and report writing skills.
- Strong written and verbal communication skills.
- Experience with root cause analysis, investigations, and problem-solving.
- Excellent understanding of regulatory expectations and inspection readiness.
