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Employer Careerwise Recruitment
Job Title Quality Engineer
Description

A Permanent Quality Engineer is required by CareerWise Recruitment for our Galway based client. The Quality Engineer will be expected to provide support to Operations, interact with customers and provide support for Engineering, Quality Systems and Process engineering. Specialisations may include but are not limited to: Design Control; Material and Process Control; Product Reliability; Software Quality Engineering; and/or Metrology.

THE ROLE:
* This position requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management, Corporate and other appropriate procedures for a variety of medical devices from concept through market introduction.
* Maintain company compliance with Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus.
* Actively participates in internal audits, CAPA System, Document/Change Control, and other activities covered under the Quality Manual, Policies and Procedures.
* Provide customer-related quality and regulatory inquiries support.
* Compiles and writes training material and conducts training sessions on QMS & Quality Assurance activities.
* Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner.
* Directs development and maintenance of internal/external standards relative to Design and Development,
* Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, Capability Assessments, MSAs, CI and Process Validation.
* Lead and provide Project Management support as needed.

REQUIREMENTS:
* Bachelor Degree in an Engineering/Science discipline.
* 3-7 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility.
* Experience with FDA and ISO 13485 Certification inspections is a plus.
* Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred).
* Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include but are not limited to Statistics, SPC, Geometric Dimensioning & Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material.
* Experience with Lean Manufacturing and Six Sigma is a plus.
* Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.
* Knowledge and experience of process validations would be advantageous

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors.

Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin.

Supporting Business Demands & Growth since 1999

CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.

This job originally appeared on RecruitIreland.com
Location Galway
Date Added 8 days ago
Apply Link
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