Operational Excellence Lead

6 days ago

Dublin, Dublin City, Ireland beBeeExcellence Full time €56,000 - €86,000

Job Overview

We are seeking a seasoned Operational Excellence Lead to spearhead our Quality Operations efforts in Dun Laoghaire. As part of our core team, you will play a pivotal role in driving quality and process excellence across the site.

Responsibilities
  • Quality Leadership: Collaborate with the site's extended leadership team to ensure 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.

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.
Benefits

Our company offers a competitive salary, 12% bonus, share options, pension, healthcare, and excellent opportunities to develop your skills and career in an exciting industry.

About Us

For nearly 100 years, our company has been accelerating the journey to better diabetes care. With the creation of the first insulin delivery device, we have delivered an innovation that moved the management and treatment of diabetes forward.

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