Based in our Waterford site and Reporting directly to the Quality Manager, the Quality Engineer will act as a Quality point of contact for systems, processes and quality activities within the site and to support the implementation and continuous improvement of quality systems in compliance with US and International regulations, laws and guidelines.

Responsibilities

• Provide guidance and feedback on quality issues
• Lead customer complaint and quality investigations
• Work with relevant departments to ensure timely closure of actions
• Participate in supplier and regulatory audits
• Support manufacturing operations to ensure products are produced to specification and the validated state of the cleanroom is maintained
• Perform critical and constructive review of procedures, processes and products
• Ensure equipment, systems, cleanrooms and products are always following applicable requirements
• Support technical transfer of products
• Own and manage relevant sections the quality management system
• Support sterility assurance activities per relevant ISO standards and internal procedures
• Support bioburden and endotoxin programs
• Promote a Quality culture and encourage Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Lead internal audits and provide guidance on suitable actions
• Support other tasks as requested by the Quality Manager. The responsibilities of the role may change and develop with the needs of the organization

Qualifications

• Minimum 3 years experience in a related role.
• Third level qualification (degree in science, engineering or related discipline preferred)
• Experience working in a manufacturing environment, preferably pharmaceutical, bio-pharmaceutical or medical device industries.
• Very good knowledge of GMP (Good Manufacturing Practice) requirements in a regulated environment.
• Takes personal responsibility for their actions. Self-starter and able to work under minimum supervision.
• Must have good communication and interpersonal skills to work in multidisciplinary teams.
• Effective oral and written communication skills are essential to this role.

• Private Medical Insurance
• Company pension
• Serious Illness Income protection
• Life Insurance
• Company and personal performance related bonus plan/structure
• Continuous Professional Development supported through Training & Development