Role and Responsibilities:

Quality Oversight & Administration:

• The Document Controller will have responsibility for controlling and managing all quality documents through the use of the Quality Management System.
• Ensure adherence to ISO 13485 standards across all Quality Management System (QMS) processes, including Document Control, Change Control, SCAR, Nonconformance, Complaint Handling, and CAPA. This involves rigorous monitoring and reporting to maintain high-quality standards and compliance.
• Preparation and revision of quality documentation to ensure compliance with the QMS.

QMS Process Management:

• Actively manage and improve QMS processes specific to an ISO 13485 environment, ensuring they meet the stringent requirements for medical device manufacturing and distribution.
• Quality Support:
• Provide ongoing support for day-to-day quality-related activities, ensuring the organization’s operations align with ISO 13485 requirements and best practices.

KPIs and Metrics Reporting:

• Regularly update and present quality KPIs and metrics to senior management, highlighting QMS performance and identifying areas for improvement.
• CAPA and Quality Review Boards Management:
• Schedule and present CAPA Review Boards and Quality Review Boards, ensuring effective resolution of quality issues and continuous improvement.

EXPERIENCE/EDUCATION/SKILLS

Qualification:

• Requires a minimum of a Level 6 NFQ (National Framework of Qualifications) or equivalent qualification in a relevant discipline, emphasizing the importance of a strong foundational knowledge of quality management systems and regulatory requirements.

Experience:

• Preference of 2 years of industry experience in document control within an ISO 13485 environment, demonstrating a proven track record of managing documents.

Skills:

• ISO 13485 Expertise: Deep understanding of ISO 13485 standards and their application within the medical device industry, showcasing the ability to implement, maintain, and improve quality systems in line with these standards.
• Strong Communication: Excellent written and oral communication skills, crucial for effective teamwork, documentation, and stakeholder engagement in a highly regulated environment.
• Data Analysis and Reporting: Proficiency in analyzing quality metrics and KPIs, with the ability to present findings clearly and make informed decisions to drive quality improvements.
• Regulatory Knowledge: Familiarity with FDA and other relevant regulatory requirements, ensuring compliance and readiness for audits.
• Problem-solving: Demonstrated ability to identify, investigate, and resolve quality issues, utilizing analytical skills to implement effective corrective and preventive actions.
• Knowledge of FDA, 21 CFR Part 820.

Job Type: Full-time

Benefits:

• Bike to work scheme
• Company events
• Company pension

Ability to commute/relocate:

• Croom, CO. Limerick: reliably commute or plan to relocate before starting work (required)

Work authorisation:

• Ireland (required)

Work Location: In perso

Please refer the Job description for details