Based near Galway city, the Quality Engineer will report directly to the Quality Manager and work in a team of 5.
- Experienced in process validation techniques including risk management, statistical techniques in compliance with regulatory requirements.
- Lead process risk management process in compliance with EN ISO 14971 and preparation of risk management files and FMEAs.
- Responsible for the compilation and execution of Process Validation Protocols in conjunction with manufacturing.
- Supports Supplier Qualification, Assessment and Audit process at key Suppliers.
- Establish and maintain incoming, in-process & final inspections requirements and support design and validation test requirements as required.
- Generates NCRs and CAPAs for product defects and non-conformities observed and follows up to ensure effective closure.
- Supports the management of all calibration and maintenance programs for all equipment.
- Manages validation and monitoring activities associated with particulate and biocontamination control.
- Manages change requests in a timely manner and ensures effective closure.
- Supports the training program and manages records for staff.
- Drives changes in procedures and standards to facilitate Drives the metrics system / trending for all quality system measurable.
- Interfaces with all departments (including Production, Design & Regulatory) on product development, transfer and improvement projects as required.
- Supports the design verification process including reviewing protocols, reports, design and quality documentation supporting product development.
- Support various Quality Management System activities including internal audits.
Skills, Qualifications & Experience
- Degree in Biomedical engineering/science discipline or Quality Management together with experience in an engineering function, preferably within a medical device or related industry.
- Minimum 2 years’ experience as Quality Engineer or similar role in a medical device manufacturing environment.
If this sounds like something you would be interested in, submit your CV today or please contact Emma on 091 455 307 if you have any questions.
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