Senior Quality Engineer

We have an exciting opportunity for a Senior Quality Engineer to join our Client, a global leader in Aerosol drug delivery devices in Galway. This is a permanent position reporting to the QA Manager and has opened due to an increased demand of our Client’s products globally. This organisation is renowned for their exceptional culture, career progression and development opportunities.

Key Responsibilities :

• Demonstrate strong leadership and a clear identifiable work ethos within the Quality Engineering Team.
• Lead Quality Engineering and support manufacturing process, driving process & continuous improvements.
• Process/manufacturing data analysis, trending, and assisting yield reporting. 
• Investigation root cause analysis of quality issues in manufacturing and managing quality related NC’s and CAPA’s.
• Establish analysis techniques and other quality control tools such as SPC, Cpk, Ppk.
• Lead the Materials Review Board (MRB) process.
• Address ongoing compliance
• Establish inspection plans, frequencies and test methods for incoming material/parts.
• Appropriately train, develop and manage resources within the Quality Engineering support team to ensure objectives are communicated and delivered within agreed requirements.
• Ensure effective and timely closure of Quality system documentation (Audit Actions, NC’s, CAPA’s, Reject Report’s etc)
• Supporting Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements.
• Overall responsibility for GMP standards and compliance within the manufacturing area
• Drive risk management activities in manufacturing (Process FMECA).
• Manage process quality control system to ensure all manufactured product meets defined specifications prior to shipment.
• Maintain compliance with ISO and FDA Quality System regulations.
• Perform other assigned tasks and support all aspects of the Quality System as directed by the Manager.

Education/Experience:

• Level 8 Bachelors degree in STEM
• 5 + years of experience in a Quality Engineering capacity.
• Good communication skills. Must have the ability to communicate effectively at all levels of the company. Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner

Thorough understanding of ISO 13485 and FDA QSR