Senior Quality Engineer with ISO 13485 and FDA QSR expertise market-leading Medical Devices company in Galway. Working with a collaborative team, you will Lead Quality Engineering support of the manufacturing process & drive process continuous improvements.

RESPONSIBILITIES:

• 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)
• Support 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 manufacturing
• 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

Requirements:

• BE / BS Degree

• 8+ years Quality Engineering experience or related role within the medical device industry

• Thorough understanding of ISO 13485 and FDA QSR

• Experience of leading and managing teams

• Ability to work on own initiative

• Strong team member with the ability to identify and drive implementation of innovative quality improvements

• Ability to consistently meet deadlines

• Demonstrate and actively promote high levels of professional quality engineering

• Must have the ability to communicate effectively at all levels of the company

• Ability to write clear, concise technical protocols and reports

• Good administrative/organizational ability with high level of attention to detail

• Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner