Operations Quality Management Expert

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €105,000
Operations Quality Management Expert

Our organization is seeking a seasoned Operations Quality Management professional to oversee and drive quality initiatives as we continue to expand our operations. This is an on-site role that offers the opportunity to make a meaningful impact on the company's success.

The Role:

  • Reporting directly to the site leader, you will be responsible for providing strategic direction and supervision to skilled and intermediate-level professionals within the quality function or unit. You will ensure the successful implementation and maintenance of the site Quality Management System and enable the achievement of quality objectives.

Key Responsibilities:

  • Develops and implements performance metrics for products and processes of moderate complexity, and drives the team to achieve Quality Goals set by management following industry standards such as ISO, IPC, AS, TL.
  • Leads medium-scale Quality Improvement Programs (QIP) in support of customer requirements and expectations.
  • Directs and influences the preparation of documentation to support high-quality regulatory submission dossiers.
  • Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
  • Mentors and trains personnel in the practices of Quality management and Quality improvement.
  • Resolves customer issues of moderate difficulty using quality tools: Root Cause Analysis and Corrective Actions that are effective and timely.
  • Provides leadership and support in areas such as analysis of nonconforming materials and customer return material authorizations, supporting customer and 3rd party audits, and the administration of Quality management.

Requirements:

  • Minimum of 7-10 years' experience in a Quality role. 2 – 5+ years regulatory affairs experience or related experience in medical device industry and/or Pharmaceuticals is required.
  • Working knowledge of FDA and international regulations.
  • Experience working directly with regulatory authorities is desired.
  • Degree qualifications (NQF L8 or L9) minimum in a related field or consideration of an equivalent combination of education and experience.
  • In-depth knowledge of quality metrics, ISO standards, and processes.
  • Knowledge of Lean and Six Sigma Manufacturing processes and controls.

This role requires a unique blend of technical expertise, leadership skills, and ability to communicate effectively with internal and external stakeholders.

For more information, please contact Michelle Mc Inerney for a confidential discussion.

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