Senior Production Quality Assurance Manager Position

2 weeks ago

Dublin, Dublin City, Ireland beBeeLeadership Full time €80,000 - €120,000

Job Title:

Production Quality Assurance Specialist

 

About This Role:

This is a senior leadership position that requires a seasoned professional to lead quality engineering teams, manage validation studies, and collaborate with various stakeholders. The ideal candidate will have a strong background in quality assurance, excellent leadership skills, and experience working in regulated industries.

 

Key Responsibilities:

  • Quality Leadership: Be a key member of the site's extended leadership team and ensure that 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.

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