Job Description
A Quality Engineer is required by Careerwise recruitment to work with a Limerick based medical device manufacturing client.
Role of this position
1. 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.
2. Collaborate with operations manager to develop and implement controls and improvements.
3. Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
4. Assign support tasks; gives instruction to technicians on supporting projects; trains technicians and provides feedback; and may coordinate technician work.
5. Investigates any Customer Complaints.
6. Participates in internal audit and supplier audit programs for relevant ISO's such as ISO 13485 and ISO 14001.
7. Lead defect resolution, root cause investigation, and continuous improvement activities.
JOB REQUIREMENTS
8. Minimum degree in a science, quality, engineering or related discipline.
9. Minimum 2 years industry experience.
10. Strong written and oral communication skills.
11. Experience working with medical device regulations.