Senior Quality Engineer

CPL

Galway

Senior Quality Engineer. The Senior Quality Engineer provides a support role to the Quality Manager in the routine maintenance of our clients Quality Management Systems and in Quality related projects. The Senior Quality Engineer reports to the QA & RA Manager. Responsibilities and Duties. Possesses and applies comprehensive knowledge of Quality. Advanced knowledge of our clients organization operations and practices to enable informed decisions and providing direction to Quality team and other functional areas. Responsibility for delivery of projects originated in QA or participate within Core Team for Quality deliverables of business wide projects. Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions. Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results. Applies risk assessment techniques in such circumstances. Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions. Drives business improvements through mentoring and support for the continuous improvement initiatives. Escalation point for quality related non-conformances and CAPAs. Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification. Requirements. Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits. Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time. Proficient with MS Word, Excel, Power Point, and management of spreadsheets. Education & Experience. Third level qualification. Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including; competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP), Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL. Broad knowledge of engineering and technical applications applied in development of medical devices useful. For more information please call Fiona Rattigan on 091 507 515 or email fiona.rattigan@cpl.ie. This job originally appeared on RecruitIreland.com.

1890 days ago