Job Title: Quality Operations Manager
Location:Pottery Road, Dun Laoghaire, Dublin.

Benefits:Competitive salary, 12% bonus, Share options, Pension, Healthcare + excellent opportunity to develop your experience and career in an exciting company.

Company:
For nearly 100 years, my client have been accelerating the journey to better diabetes care. With the creation of the first insulin delivery device, they have delivered an innovation that moved the management and treatment of diabetes forward.

Overview:
In this role you are responsible for leading critical projects for new product introduction at embecta Dun Laoghaire. This involves providing leadership to the Quality Engineering team (5-7 associates) , managing validation studies, and working closely with various internal and external stakeholders.

Responsibilities:

Quality Leadership: Be a key member of the Dun Laoghaire Quality Leadership Team and the site’s extended leadership team, ensuring our quality systems align with ISO standards and regulatory requirements.

• Team Management: Lead, inspire, and develop the Quality Engineering Team, fostering collaboration, delegation, and performance excellence through regular reviews and goal-setting.
• Continuous Improvement: Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies.
• System Oversight: Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.
• Quality Control: Oversee the activities of the Quality Control group, ensuring seamless integration and high performance.
• Drive Change: Lead key improvements in quality assurance and control systems, championing innovation and operational excellence.
• Collaborate Externally: Build strong relationships with external customers, ensuring their needs and expectations are met.
• Regulatory Excellence: Ensure timely and compliant completion of CAPAs, maintain high-quality documentation, and prepare for audits with confidence.
• GMP Compliance: Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.

• A third-level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is a plus
• 5+ years in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry.
• At least 3 years of supervisory experience with a proven track record of team development.
• Experience preparing technical documentation and managing CAPA systems.
• Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus).
• Knowledge of FDA requirements and experience managing FDA audits.
• Experience with process validation, sterilization, and clean room environments is advantageous