Cache of job #14096886

Job Title

Quality Engineer - NPD

Employer

SIGMAR RECRUITMENT

Location

GALWAY

Description

Quality Engineer - NPD/Sustaining. Located within R&D, this Quality Engineer will be a part of a division dedicated to "quick-thinking" strategies for Next-Gen devices and Sustaining activities. Responsibilities: Support and provide Engineering input to Design, Manufacturing and Operations. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Apply sound, systematic problem-solving methodologies in identifying, prioritizing. Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings. Knowledgeable on Risk Management, BSEN 14971 requirements. Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes. May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements. Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality. Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff. Background: NFQ Level 8 qualification in Engineering, Science or relevant discipline. Minimumof3-4 years experience in a Quality Engineering capacity. Good technical capabilities, communication skills, teamwork abilities and initiative. Proven ability to work well both as part of a team but also able to work on own with minimum supervision. Proven ability to work well as part of a team & on own with minimum supervision. Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards. Experience in nonconforming material and CAPA methodologies/systems preferred. Strong communication, presentation, facilitation, and project management skills. Experience working in cross-functional teams and driving projects to completion. Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent. High sense of urgency and commitment to execution. Applies continuous improvement principles in development of the quality system. Driven, energetic, self-assured professional with high personal integrity. For more information, please contact Emma on 091 455 307. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Date Added

1525 days ago

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