Our client, a medical device company in Galway is currently looking to recruit Quality Engineer for their site.
The Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.
- Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485
- FDA QSR
- ISO 14000
- Ensuring continued compliance with DMR
- Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
- Trend analysis of data from the controls
- Potential improvements for review with engineering based on the trends.
- Areas for Improvement to senior management.
- Review and propose changes to sampling plans based on trend analysis and changes to the system.
- Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements.
- Support the Complaint/CAPA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
- Execution of Quality Validations and preparation of associated documentation as required.
- Review, update and approve Quality procedures as required through ECO process.
- Action NCR and CAPA in an appropriate and timely manner.
- Raise appropriate Variation Permits as required, in line with customer and regulatory requirements.
- Support Customer and Regulatory Audits.
- Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner.
- Engineering Change Order (ECO).
- Complaint/Corrective and Preventative Action (CAPA).
- Material Review Request (MRR).
- Internal Audits.
- Failure Mode Effect Analysis (FMEA).
- Variation Permits (VP).
- Project meeting attendance and provision of quality support as required.
- Attend and participate in daily cell meetings.
- Preparation of information for KPI and Management Review meetings.
- Ability to communicate and work with people inside and outside the department.
- Good communicator (written and oral).
- Ability to train and lead where required.
- Ability to co-ordinate, plan and organise in a timely manner.
- Knowledge of engineering theories and methods.
- Good technical report writing skills.
- Rigorous attention to detail.
- Engineering or science Degree preferably with Quality Engineering included.
- Quality Department or similar experience in regulated industry.
For further information on this Quality Engineer role in Galway please contact Orla on 086 0449473 / email@example.com
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