Ref No: AM17327
Wicklow, Co. Wicklow, Ireland
Quality Engineer - South Dublin.
This position is being offered initially as a 1 year fixed-term contract.
In this role you will provide guidance on all aspects of manufacturing systems to ensure that product and processes meet the required specifications, duties are performed within the regulations, and the Quality System is maintained.
Promote the Quality system usage and compliance to avoid product field actions, or major non-compliance in external audits.
Provide guidance on regulatory and quality requirements to ensure consistent product supply is maintained and all quality aspects are met.
Ensure that non-conforming equipment, suppliers, manufacturing activities, reworks and testing activities, are noted and addressed for appropriate actions to ensure that product safety and effectiveness is addressed.
Ensure participation in the Investigation Management System is addressed across the product lifecycle, including investigation of customer complaints where needed.
Assist in the review of product and process changes to maintain and meet regulatory guidelines.
Maintain and update risk management files as required by regulatory guidance.
Work constructively with team members from cross-functional teams, Supply Chain, R&D, Marketing, and Technical Support group to attain outcomes.
Communicate progress on a frequent basis and maintain metrics as needed.
Interested applicants should have:
• A life science degree or similar, with experience in medical devices or biological sciences
• At least 1-4 years' industrial experience, ideally to include experience in the diagnostic/medical device/pharmaceutical industry
• Demonstrated competence in biochemical techniques and statistical concepts.
• Experience in the field of Haemostasis/ IVD industrial experience would be advantageous (not essential)
• Ability to read, analyse, and interpret technical data, and technical procedures.
• Ability to prepare Powerpoint presentations.
• Ability to effectively present information and respond to questions from groups of managers, clients, and customers.