Creganna-Tactx Medical

Galway, Ireland

Responsibilities:

• Provides leadership and direction to a team of quality system engineers, document control and training specialists;
• Responsible for day to day activities relating to quality system architecture, work processes, and quality systems staff for Creganna Tactx Medical Galway;
• Responsible for overall development, deployment and maintenance of quality system elements, documentation change control, procedures, and supporting systems;
• Responsible for coordinating and managing all customer audits, notified body audits, and FDA inspections;
• Responsible for managing the site internal audit process;
• Responsible for managing the site internal CAPA process;
• Responsible for managing the site training compliance process;
• Responsible for the coordination, preparation, initiation, follow-up, and closure of all corrective actions issued as a result any audits;
• Ensures Product Lifecycle Risk Management activities are performed and maintained;
• Actively stays current with external and internal quality system standards and requirements;
• Demonstrates broad knowledge of medical device regulations and guidance documents;
• Implements, and communicates new or revised Quality System/Regulatory Compliance policies and procedures including training;
• Ensures alignment of overall quality systems architecture from SOP to manufacturing work instructions across multiple business units and product types;
• Assists in the preparation and maintenance of records associated with the management review process;
• Identifies deficiencies in quality systems and defines systematic corrective actions;
• Develops effective quality metrics and communicates the results to key stakeholders using reports, presentations, and dashboards;
• Participates in Quality Systems Projects under the direction of the Quality Director as well other duties, as assigned.

Education/ Requirement:

• Bachelor of Arts or Science degree in Engineering / Science or the equivalent in education and experience required.

Experience Requirements:

• A Minimum of five (5) years of experience in medical device manufacturing. Quality Systems experience in an FDA regulated environment (QSR) is preferred.
• ISO 13485 and MDD experience preferred;
• Ability to work independently under general guidelines and supervision;
• Effective interpersonal skills as demonstrated through prior supervisory experience;
• Ability to adapt to changing duties and responsibilities.

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