Operations Excellence Manager

4 days ago

Dublin, Dublin City, Ireland beBeeLeadership Full time €85,000 - €105,000

Job Overview

This role involves leading critical projects for new product introduction at our site. The successful candidate will provide leadership to a team of quality engineers, manage validation studies and work closely with various internal and external stakeholders.

Key Responsibilities:

  • Quality Leadership: As a key member of the quality leadership team, you will ensure that our quality systems align with ISO standards and regulatory requirements.
  • Team Management: You will lead, inspire and develop a team of quality engineers, fostering collaboration, delegation and performance excellence through regular reviews and goal-setting.
  • Continuous Improvement: You will partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies.
  • System Oversight: You will manage key quality system elements including non-conformance processes, incident reporting and customer complaint analysis.
  • Quality Control: You will oversee the activities of the quality control group, ensuring seamless integration and high performance.
  • Drive Change: You will lead key improvements in quality assurance and control systems, championing innovation and operational excellence.
  • Collaborate Externally: You will build strong relationships with external customers, ensuring their needs and expectations are met.
  • Regulatory Excellence: You will ensure timely and compliant completion of CAPAs, maintain high-quality documentation and prepare for audits with confidence.
  • GMP Compliance: You will 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:

Competitive salary, 12% bonus, share options, pension, healthcare and excellent opportunity to develop your experience and career in an exciting company.

About Us:

We have been accelerating the journey to better diabetes care for nearly 100 years. 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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