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Lake Region is proud to be an equal opportunity employer. We are always seeking talented, motivated, and innovative people to join our dedication to delivering precision products to minimize patient suffering.
Senior Quality Engineer Location: New Ross, Co Wexford, Ireland
The Senior 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.
Developing and maintaining quality world class systems related to the manufacture of guide wires while developing employee efficiencies
Direction for quality in two product manufacturing areas
The co-ordination and control of one of the key components of the Lake Region Medical quality system.
Direction of the relevant inspectors in area of responsibility
Direction of the relevant quality engineers in area of responsibility
Playing a role in the plant annual objectives.
Ensure continued compliance with all Regulatory Standards. This includes:
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.
Support the RCA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner
Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
Participation in validation protocol development
Overseeing completion of validation or validation samples
Supporting the manufacturing engineering function to ensure compliance to related element of quality system.
Supervision of quality engineer to ensure compliance for their areas of responsibility for
implemented process controls,
assuring product quality,
qualification and validation
quality direction for RCAs, RTAs, technical issues related to regulatory queries,
Project meeting attendance as required
Attend and participate in daily cell meetings
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
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
Minimum Education and Experience Requirements:
Engineering or science Degree preferably with Quality Engineering included.
Minimum 5-7 years relevant experience within a regulated environment