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Manufacturing & Production

Engineering & Technical

Job Description

An Exciting New Quality Engineer position with a Medical Device Company who is involved in Prototying, Design & Delivery of Medical Devices concepts. Really energizing position for a Quality Engineer based in Sligo.

Role of this position

  • Assist with the development and maintenance of quality evaluation and control plans and protocols for processing materials into finished products.
  • Assist with the confirmation that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements.
  • Issue of Product paperwork/batch records to manufacture and review and release of same and compile COA/COC
  • Approval of change requests for product, process and quality changes.
  • Generation and management of process deviations, non-conformances, supplier complaints, reworks, CAPA, complaints, rejects and change notices.
  • Preparing and updating Operations procedures and associated documentation.
  • Quality review of responsible area validation documentation.
  • Performing an active role in further development and continuous improvement of the QMS.
  • Liaise with suppliers and customers on quality related issues.
  • Assist Head of Quality in implementing and maintaining the QMS.
  • Conduct internal audits, including closing out audits in a timely manner, creating audits finding reports and determine proper corrective and preventive actions.
  • Create, maintain and issue company quality documentation, such as SOP's, and WI's.
  • Support customer and surveillance accredited audits.
  • Drive continuous improvement and best practices in QMS "Right First Time".
  • Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations.
  • Updates job knowledge by participating in educational opportunities.
  • Ensure compliance to all applicable regulatory standards and cGMP procedures and practices.

JOB REQUIREMENTS

  • Minimum Degree in a Science or Engineering discipline.
  • 3-5 Years' experience working in a medical device environment in a Quality role.
  • Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
  • Internal/external auditing experience would be an advantage.
  • Validation experience including Sterilization, process and packaging validations would be beneficial.
  • Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.
  • Understand general principles of ISO 14971.

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@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.

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Manufacturing & Production

Engineering & Technical

Cork Office

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

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie