Quality Engineer
Pale Blue Dot® Recruitment
Limerick
Our client, a medical device engineering company based in Limerick who specialize in manufacturing precision components are seeking a Quality Engineer to join their team.
Responsibilities include but are not limited to:
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.
May develop, update, and maintain technical content of risk management files.
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.
Support FMEA and Inspection development to ensure that all failure modes in process have been identified and addressed.
Coordinate quality data and reporting of KPIs to drive continuous improvement and feed into management review.
Project activities as required from NPI projects.
Lead site change control activities.
Other incidental duties assigned by management.
Lead and develop quality administrator.
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.
Strong computer skills.
Internal auditor courses for relevant ISO.
Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.
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