Job Description:
Quality Engineer
JOB SUMMARY
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.
Accountabilities include:
Ensure continued compliance with all Regulatory Standards. This includes:
o ISO 13485 with particular support to the environmental monitoring requirements.
o FDA QSR
o ISO 14000
o Ensuring continued compliance with DMR
Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
o Trend analysis of data from the controls
o Potential improvements for review with engineering based on the trends.
o Areas for Improvement to senior management.
o Review and propose changes to sampling plans based on trend analysis and
changes to the system.
Maintain and develop vendor management program consisting of;
o Development and establishment of new vendors
o Servicing existing vendors
o Dealing with all vendor non-compliances
o Supporting the purchasing function to ensure compliance to related element of quality system.
Maintain and develop the calibration and environmental monitoring system including participation in bio-compatibility monitoring.
Maintenance of customer concerns handling system in a timely manner including
o Returned product analysis
o Organisation, filing and reporting of customer concerns
Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements.
SKILLS AND KNOWLEDGE:
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.
Knowledge of environmental requirements for clean rooms and related product testing.
Rigorous attention to detail.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
Engineering or science Degree preferably with Quality Engineering included.
Qualified systems lead auditor
REPORTING RELATIONSHIP AND PRESENCE OF SUPERVISOR.
This position reports directly to the Senior Supervisor for Quality Engineering.
Please forward c.v in the strictest of confidence to Martin OLeary moleary@brunel.ie or call on 051-309652 for more information.