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Reliability Quality Engineer - Project Manager

Job Title: Reliability Quality Engineer - Project Manager
Contract Type: Permanent
Location: Mayo
Industry:
REF: 122810
Contact Name: Larry O’Leary
Contact Email: larry@rftgroup.ie
Job Published: 8 months ago

Job Description

Reliability Quality Engineer - Project Manager
Our client a healthcare manufacturer based in Connaught, now seeks an experienced Quality Engineer who will provide leadership to implementing and maintaining a Reliability Regime throughout the organisation, in line with the QMS.

The successful candidate will ensure a reliable production system, including; the process design stage, process specification, procurement and provision of equipment and facilities, together with supply chain and day-to-day working practices.

This role will work closely with Quality function on the design & performance of regime methodology, Production on the implementation in commercial operations, Engineering on the application in process design, Validation on the application in tech transfer and validation. This role will reports directly to the Associate Director Quality.

Responsibilities Reliability Quality Engineer - Project Manager:
Lead reliability management and work on developing a site wide framework for the regime.
Identify a suitable process by which the approach will be piloted.
Liaise with Finance & Planning regarding metrics development, collection & review.
Analyze and manage the risk management process for prospective changes (e.g. NPIs) and for issues arising (e.g. deviations) as deemed necessary by identifying, measuring, and making decisions.
Develop and implement appropriate risk-assessment models or methodologies
Co-ordinate and direct the Production Reliability Regime for the site
Manage the Production Reliability Regime in a facilitatory manner for new projects (prospective) & issues arising (reactive).
Train & mentor personnel on the principles of reliability management.
Liaise with Finance & Planning regarding metrics development, collection & review.
Identify & sponsor Continuous Improvement programs.
Ensure effective recording, analysis and reporting of indicators for reliability management, ensuring issues impacting performance are addressed and drive continuous improvement.
Representative at project meetings and make robust decisions in support of project needs ensuring quality needs are understood and implemented from a Production Reliability perspective

Requirements for Reliability Quality Engineer - Project Manager:
Bachelor's Degree in Science, Engineering, Operational Excellence or similar technical qualification.
Proven track record in a quality discipline in pharmaceutical or medical devices, FDA regulated industry.
Proven experience of working in a cGMP manufacturing environment.
Practical working knowledge of statistical data analysis and quality improvement tools and techniques an advantage.
Experience using proven risk management tools.

Larry on 01-2302400 / larry@rftgroup.ie


The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/


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