Quality Systems Specialist – Senior required for a leading medical device company based in Limerick. The companies FDA regulated Limerick facility has grown consistently over the last 20 years to become one of the most important sites in its global operations. This facility specialises in the production of disposable contact lenses in a state of the art operation which includes injection moulding, robotics, vision systems and sterilisation systems in a Class 100,000 cleanroom environment. The facility has over 50 fully automated manufacturing lines and the product is untouched by a human hand from start to finish of the process.
In this role the Quality Systems Specialist – Senior will:
o Drives compliant execution of the following for their assigned processes and projects
o Manages specified quality system processes.
o Works directly with various customers of the quality system processes to ensure compliance to site/sector/enterprise /franchise/regulatory requirements
o Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner
o Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings. Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards.
o Understand and uses data, key metrics and statistical methods, quality tools or computer based solutions to improve processes
o Responsible for identifying and communicating the need for process improvement opportunities to responsible management.
o Identifies personnel that require training on the relevant processes and rolls out training as required.
The Quality Systems Specialist – Senior requires:
o Degree in a Quality, Science or Engineering discipline and 3 to 5 or more years of related experience
o Experienced SME for FDA and other regulatory authority audits.
o Proven leadership skills
o Successful Completion of Global Projects
o Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems
o Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met.
If this role is of interest, please call Kathy at LSC on 021 4777 329 or apply directly through this advert