Operations Quality Engineers

Careerwise Recruitment

Galway

3 x operations quality engineers required by careerwise recruitment for our galway based client. operations quality engineer is a member of the operations quality group. responsible for operations quality within their prescribed area of functional responsibility and will be working as part of a team to maintain high quality / performance standards on all products. this challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the quality system (iso 13485). please contact tom devaney for more information. the role: * overall responsibility for production gmp standards and compliance. * investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues. * establishing inspection standards, plans, frequencies and test methods. * establishing and maintaining fmeas. * preparing and updating operations procedures and associated documentation. * reporting area of responsibility metrics. * supporting customer and surveillance accreditation audits. * the quality engineer will perform an active role in quality planning and new product introduction from a quality perspective. * have a good working knowledge of iso/fda/mdd and other product development related regulatory requirements. * maintain relevant documentation to comply with quality standards and customer requirements. * develop strong links with customer organisation's and other project stakeholders. * quality review of responsible area validation documentation. * performing an active role in further development and continuous improvement of the quality management system. * support operations area projects and initiatives i.e. kaizen, cfps, etc. requirements: * degree in quality or degree in science / engineering. * experience within a similar role as quality engineer. * 5 yrs industry experience in a medical device-manufacturing or pharmaceutical environment. * working knowledge of fda and iso quality systems for medical device companies. * new product introduction and manufacturing process transfer experience would be a distinct advantage. * quality experience in component and device manufacturing desirable. * excellent written and oral communication skills essential. 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. please call tom devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. careerwise recruitment. in search of excellence. we provide recruitment services in the areas of engineering, supply chain, sciences, it and accounting & finance. we operate out of multiple locations in ireland and have offices in cork, shannon, galway and dublin. supporting business demands & growth since 1999. this job originally appeared on recruitireland.com.

2135 days ago