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Manufacturing & Production

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Job Description

A Validation Engineer is required by CareerWise Recruitment for our Sligo based client for a permanent position. If you are interested in working for a Medical Device company in Sligo then this is the position for you.

Responsibilities

  • Co-ordinate all validation activity within the company working directly with the Engineering & Operations Departments.
  • Lead the project validation team, support the completion of process, systems, software and equipment validations and revalidations in accordance with Validation Master Plans.
  • Working within the QMS, support the Quality Engineering Team as required.
  • Provide ongoing guidance and support to all departments relating to process & equipment change control, and the requirements to validate / revalidate.
  • Ensure ongoing compliance, as applicable, with ISO13485 and other related Guidance Documents
  • Prepare and review of validation / qualification plans, protocols, reports, and amendments
  • Build a strong relationship with internal & external customers by delivering reports/protocols etc. on time per the project plan
  • As required, coordinate & discuss validation activity with customers and in line with their requirements.
  • Represent Validation area at internal audits, external audits, and on cross functional teams including CFTs for risk assessment, CAPA, Continuous Improvement, new product introductions
  • Be responsible for the maintenance of the validation procedure and train relevant personnel
  • Participate in cross functional teams to establish validation strategies and objectives, determination of sampling techniques and statistical analysis.
  • Monitor the progress of validation projects on a daily/weekly/monthly basis ensuring that there is continuous drive/focus on meeting schedules.

Requirements
  • Third level qualification to Degree level in Quality, Engineering, Science or related discipline.
  • Knowledge of validation practices as used within the FDA / ISO 13485 environment.
  • Knowledge of Quality Standards, Validation Regulations and Guidance Documents required
  • Minimum 2-3 years in a similar role in the medical device industry preferred.
  • Have the ability to work within the QMS using own initiative.

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