See All Jobs

Manufacturing & Production

Engineering & Technical

Job Description

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. CAPA & Project Management experience desired...Please contact Tom Devaney for more information.

Role of this position

  • The Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system.
  • The Quality Engineer will perform an active role in quality planning and New Product Introduction from a quality perspective.
  • Establish and maintain risk management principles and methods throughout the product realisation process in compliance with the company's Quality Management system and ISO14971.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Offer quality guidance to a team of Quality Technicians in support of the day-to-day manufacturing operations.
  • Develop strong links with customer organisation's and other project stakeholders.
  • Quality review of responsible area validation documentation.
  • Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues.
  • Overall responsibility for production GMP standards and compliance.
  • Establishing inspection standards, sampling plans and test methods.
  • Preparing and updating Operations procedures and associated documentation.
  • Supporting customer audits and surveillance / accreditation audits.
  • Conducting audits of the manufacturing operation and the Quality system ensuring compliance with ISO13485.
  • Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.

JOB REQUIREMENTS

  • Level 8 Degree in Quality or Science / Engineering A PREREQUISITE.
  • Experience within a similar role as a Quality Engineer.
  • 3+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 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.

Apply Now

Manufacturing & Production

Engineering & Technical

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie