Elite Talent Hub LTD is a specialist in permanent staffing solutions for clients globally.
Elite Talent Hub are seeking a highly motivated and detail-oriented Quality Systems Specialist to join a medical device company located in Limerick. The ideal candidate will be responsible for supporting and maintaining a Quality Management System (QMS) to ensure compliance with regulatory requirements and industry standards. This role will be pivotal in enhancing product quality and safety while supporting continuous improvement initiatives within the organisation.
Key Responsibilities:
- Assist in the development, implementation, and maintenance of the company’s QMS in accordance with ISO 13485, and other applicable standards and regulations.
- Conduct internal and supplier audits to ensure compliance and identify opportunities for improvement.
- Support the preparation and response to regulatory inspections and audits.
- Review and approve quality documentation, including design history files, validation protocols, and corrective and preventive action (CAPA) reports.
- Provide guidance and training to staff on quality procedures, practices, and regulatory requirements.
- Monitor and analyse quality metrics, generating reports and recommending actions for process improvements.
- Collaborate with cross-functional teams to ensure product quality and adherence to standards throughout the product lifecycle.
- Assist in the management of non-conformances, investigations, and root cause analysis.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum of 1+years of experience in quality systems management within the medical device or related healthcare industry.
- Knowledge of ISO 13485 and other relevant regulatory standards.
- Experience with internal and supplier auditing practices.
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