At our Projects Engineering Department in Athlone we focus on providing stable, flexible and cost effective solutions to enhance our processes and systems that produce the highest quality products through the deployment of innovative engineering projects and solutions. Quality Engineers are directly involved in understanding and providing compliance solutions and documentation throughout the project lifecycle, designed to continuously improve our manufacturing processes, systems, quality and regulatory compliance to the highest standards.
Come for a job, stay for a career!
A DAY IN THE LIFE OF:
* Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
* Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
* Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
* Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
* Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
* May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
* As part of process improvement projects, prepare the process validation protocols and work with the relevant process engineer in terms of execution of the validation and documentation of the resulting test report.
* Lead deployment of root cause analysis tools and approaches through the organization with a specific focus on deviation resolutions.
* Liaise with process engineers and other departments as relevant on the revalidation/introduction of new automation/tooling /processes/software/utilities /product to ensure that all aspects of validation are being covered
* Risk Management - As part of a team co-ordinate the completion of Risk Management to include the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis etc. to all product groups.
* Suggest relevant changes to procedures and update to standard operating procedures as necessary.
* Work with supervisor in terms of establishing gaps in the Project Validation Master Plans, creating schedules/timelines to address same and regularly reviewing the Master Validation Plan for adequacy
* Provide quality engineering support to your functional area, helping to drive improvements, contributing to investigating root cause of quality issues and following through on corrective actions to prevent reoccurrence.
* Liaise with cross functional team members, developing strong partnering relationships with these to establish inspection methods which ensure effective product acceptance actives.
* Generate and understand of product construction, features and use at a competent level in order to make decision on product acceptance standards within the scope of your responsibility.
* Support on-going communication through reports and information transfer as needed.
* Develop and maintain analysis techniques and other quality control tools to aid in decision making.
KEY SKILLS & EXPERIENCE
* Qualified person to third level 8 degree in a relevant Quality/Engineering/Science related discipline.
* Preferably with 4-6 years relevant experience in a medical devices or similar regulated environment, with at least 3 years in a comparable role.
* Dynamic team player and leader, with the ability to work effectively and proactively on cross-functional teams
* Ability to be self-directed and to effectively interface with various levels and functions within the organization
* Results driven and dynamic team player and can work effectively and proactively on cross-functional teams.
* Knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies. Knowledge, understanding and implementation of GAMP5 is an advantage.
* Experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques.
* Think critically and make sound decisions.
* Focused on patient and customer and set high standards, instill operational excellence, and drive accountability.
* Excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken.
* Excellent organizational skills and have the ability to prioritize and work effectively on multiple projects.
* Good communication skills.
* Fluent in English, both in writing and speaking
A very attractive Salary/Benefits Package is on offer and negotiable
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland