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 will 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 of 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
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 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
Benefits
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
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