Job Overview
* Seeking a highly motivated and detail-oriented professional to join our quality management team as Quality And Compliance Specialist.
Key Responsibilities
1. Develop and implement quality policies and procedures aligned with industry standards, ensuring compliance with ISO 9001, ISO 13485, ISO 17025, and ISO 27001.
2. Collaborate with cross-functional teams to foster a culture of continuous improvement, driving commercial growth while maintaining quality standards.
3. Manage the development and maintenance of integrated systems, ensuring seamless operation and effective issue resolution.
4. Partner with managers and staff to address non-conformances, enhance procedures, and deliver quality-focused training programs.
5. Oversee supplier and product onboarding, ensuring market accessibility in line with MDR/IVDR requirements and EU regulations.
6. Liaise with regulatory bodies such as NSAI, INAB, and HPRA on quality and regulatory matters, ensuring ongoing compliance.
7. Monitor regulatory changes and provide guidance on necessary actions to maintain accreditation and certification.
8. Lead the operation and maintenance of the calibration laboratory, ensuring accurate performance and final approval of accredited calibration certificates.
Requirements
* Proven track record of quality improvement initiatives and compliance with industry standards.
* Excellent communication and interpersonal skills, with the ability to build strong relationships with colleagues and stakeholders.
* Confident in working with complex standards, audits, and regulatory frameworks.
* Passion for career growth and development in quality and compliance within a respected organization.