Our client, a leading medical device company dedicated to improving patient outcomes through innovative solutions, based in County Mayo, is looking to hire a Quality Systems Specialist as they expand operations.
The Role:
As the Quality Systems Specialist, you will play a pivotal role in managing and enhancing the company’s Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
Responsibilities:
* Quality Management System: Manage and maintain the QMS, ensuring compliance with relevant standards and regulations (ISO 13485, FDA, EU MDR, etc.).
* Document Control: Oversee the creation, review, approval, and archiving of quality documents, including procedures, work instructions, and records.
* Internal Audits: Plan, conduct, and report on internal audits to ensure compliance with the QMS and identify areas for improvement.
* CAPA Management: Lead Corrective and Preventive Actions (CAPAs) to address non-conformances and drive continuous improvement.
* Training: Develop and deliver quality-related training programs to employees, ensuring awareness and understanding of quality requirements.
* Supplier Quality: Collaborate with suppliers to ensure quality standards are met and assist in supplier audits as needed.
* Regulatory Inspections: Support external audits and inspections by regulatory authorities, including preparation, facilitation, and follow-up actions.
* Data Analysis: Monitor and analyze quality metrics, trends, and KPIs to identify opportunities for improvement.
* Change Control: Manage change control processes to ensure all modifications are compliant with quality and regulatory standards.
Requirements:
* Bachelor’s degree in Engineering, Science, or a related field.
* 3+ years of experience in a quality role within the medical device or regulated industry.
* Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.
* Experience with QMS software and document management systems.
* Excellent problem-solving and analytical skills.
* Strong organizational skills with the ability to manage multiple priorities.
* Effective communication and interpersonal skills.
* Internal or Lead Auditor certification (desirable).
For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.
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