Our client, a leading multinational company based in Galway, is seeking to hire three Quality Engineers for an initial 12-month contract, with the potential to turn permanent.
The Role:
The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the Quality Management Systems and in moderately complex Quality related projects.
Responsibilities
1. Possesses and applies a broad and increasing knowledge of Quality, and its application to complete moderately complex assignments.
2. Broad knowledge of operations and practices to enable informed decisions in day-to-day operations and assignments.
3. Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues.
4. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/incomplete information.
5. Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.
6. Drives business improvements through continuous improvement initiatives.
7. Acts as an escalation point for quality-related non-conformances and CAPAs.
8. Drives compliance cross-functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
Requirements
1. Third level qualification.
2. Minimum 5 years of experience in the medical device industry with a minimum of 3 years in progressively responsible positions.
3. Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP).
4. Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL).
5. Broad knowledge of engineering and technical applications applied in the development of medical devices is useful.
6. Excellent interpersonal, written, and verbal communication skills, including the ability to make clear, well-founded decisions regarding conformity during audits.
7. Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
8. Proficient with MS Word, Excel, PowerPoint, and management of spreadsheets.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
Skills:
Quality Engineer, CAPA
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