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A Quality Engineer is required by Careerwise recruitment to work with a Limerick based medical device manufacturing client.
Role of this position
* Investigate manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
* Collaborate with operations manager to develop and implement controls and improvements.
* Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
* Assign support tasks; gives instruction to technicians on supporting projects; trains technicians and provides feedback; and may coordinate technician work.
* Investigates any Customer Complaints.
* Participates in internal audit and supplier audit programs for relevant ISO’s such as ISO 13485 and ISO 14001.
* Lead defect resolution, root cause investigation, and continuous improvement activities.
JOB REQUIREMENTS
* Minimum degree in a science, quality, engineering or related discipline.
* Minimum 2 years industry experience.
* Strong written and oral communication skills.
* Experience working with medical device regulations.
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