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Quality Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22627

Our client based in Oranmore Co Galway have an exciting opportunity for a Quality Engineer to join their operations team.

The Role:

You will play a pivotal role in ensuring the quality and compliance of company xxx manufacturing processes while contributing to the delivery of medical devices that change lives.

Responsibilities:

  • Develop, implement, and maintain quality assurance procedures and methods for control of materials and finished goods. 

  • Work as a key member of the operations team and with suppliers to ensure quality standards are met and maintained.

  • Develop and execute product quality control plans, documents and procedures.

  • Provides input to risk analyses and Process Failure Mode Effect Analysis’ (pFMEAs) including with suppliers.

  • Implement and enhance quality principles, gather and analyse quality data to support product/process improvement activities. .

  • Oversee manufacturing related quality events in line with GMP and internal procedures, including process defects, CAPA, and complaint investigations. Disposition non-conforming material and work with manufacturer and suppliers to implement corrective and preventive actions. 

  • Provide quality guidance as an integral member of the operations team, influencing manufacturing activities.

  • Provide quality input into process validation activities.

  • Monitor quality records’ compliance and maintain documentation according to Quality System requirements.

  • Assist with change control and calibration activities. 

Requirements:

  • A Post-graduate qualification in Quality Assurance is preferable although not mandatory.

  • At least three years Quality Engineering experience or related role within the medical device industry.

  • Experienced working in a medical device manufacturing environment complying with Good Manufacturing Practices.

  • Ability to work on own initiative with limited supervision/guidance.

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

  • Ability to collaborate and work with external suppliers and project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately.

  • Good communication skills. Must have the ability to communicate effectively at all levels of the company and with suppliers.

  • Process Validation experience desirable.

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

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

  • Thorough understanding of ISO 13485 and FDA QSR standards.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717