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.
- 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.
- 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: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)