Quality Engineer

CAREERWISE RECRUITMENT

GALWAY

A Quality Engineer for Operations, is required by CareerWise Recruitment for our Galway based client. The Operations Quality Engineer is a member of the Operations Quality group and is responsible for Operations Quality within their prescribed area of functional responsibility. They will be working as part of a team to maintain high quality / performance standards on all Medical products. This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the Medical Quality System. 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 FMEA's. * 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/ISO/MDD 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. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1365 days ago