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Quality Assurance Manager

1 week ago

Dublin, Dublin City, Ireland Life Science Recruitment Full time

Overview

In this pivotal role as a Quality Operations Manager, you will lead 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.

Key Responsibilities:

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

Requirements:

  • 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.