Our client, a reputable leader in the medical device industry, dedicated to innovation and unwavering commitment to safety and quality, is currently in search of a highly motivated and experienced Quality Systems Support professional to join their dynamic team.
Be the process expert for Quality Management Systems, ensuring a deep understanding of processes and products.
Lead and support the resolution of quality issues, overseeing root cause investigations and implementing effective corrective and preventive actions.
Assess changes to quality processes and determine if validation or re-validation is required.
Evaluate process capacity and set standard times in alignment with manufacturing plans.
Develop additional process capacity as necessary to meet production requirements.
Continuously evaluate and enhance process capability to optimize efficiency and quality.
Create and maintain comprehensive work instructions for manufacturing processes.
Collect and analyze quality data, focusing on Key Performance Indicators (KPIs) related to complaints, corrective actions, non-conformance reports, and continuous improvement.
Identify equipment and tooling needs and initiate replacement programs.
Ensure the maintenance of safe and compliant processes.
Conduct risk assessments and manage changes using the Management of Change (MOC) process.
Lead quality-based continuous improvement initiatives and maintain a structured idea hopper.
Maintain a regular reporting cadence on Quality Management projects.
Provide support for critical KPIs related to Safety, Quality, and Service.
Assist in regulatory affairs and international submissions.
Support programs related to material, component, and document obsolescence.
Contribute to manufacturing scale-up and New Product Introduction (NPI) integration efforts.
A minimum of a Level 8 degree, preferably in a physical/life science or engineering discipline.
Previous experience in the Medical Device industry with exposure to ISO 13485 and US FDA regulations is desirable.
Certification as an auditor to ISO 13485 would be highly advantageous.
Proficiency in Quality Management Systems, including Complaints, CAPA, NCR, and audit management.
Strong computer skills and experience with automated management systems.
Exceptional communication and interpersonal skills, capable of conveying technical information to diverse audiences.
Problem-solving skills and decision-making ability.
A keen attention to detail and the ability to maintain high standards despite deadlines.
For more information please contact Cathal Herron:
(090) 645 0660