Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.
Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart. Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL works with doctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond.
For our Nordson MEDICAL facility in Galway, Ireland, we are looking for an experienced Quality Engineer to support Design assurance activities across a range of balloon catheter / delivery systems projects throughout the design cycle. At our Galway facility we focus on design and manufacture balloon components and catheters / deliver systems.
Essential Job Duties and Responsibilities
As a Quality Engineer you will be part of the project teams to advance projects utilising Nordson MEDICAL: Quality Systems and ensure appropriate regulations and industry standards throughout the product development process are achieved.
As part of the project teams you will lead activities such as risk assessments, sterilisation, Biocompatibility and verification testing. You will contribute to design / phase reviews to help ensure the team meet all requirements during the design cycle. As part of the team you will contribute to all documentation requiring Quality support during the design cycle.
Other key activities include complaints investigation, supplier qualifications, CAPA completion and closure, change control during design phases, design history file and device master record.
Work with the project teams to enhance the quality system from a design perspective to ensure we meet various regulatory requirements and ensure we are continuously improving the design cycle process.
Education and Experience Requirements
Minimum Bachelor's degree in Engineering or related field;
5 -10 years of medical device design and development/quality assurance experience is required;
Experience working with operations to develop strong manufacturing process instructions and operator training to ensure smooth product transition into the manufacturing environment is desired;
Experience using an electronic quality management system (eQMS) a plus;
Lean or Six Sigma certification/experience preferred;
Auditor experience preferred (i.e. Supplier, Customer, Third Party, Quality Management System (QMS)).
Skills and Abilities
Ability to interact with client companies in a professional manner;
Demonstrated ability to lead product verification & validation activities;
Familiarity with FDA QSRs, medical device regulations and ISO 13485;
Depth of knowledge in one or more specialized areas, e.g. Biocompatibility, sterilization methods, etc;
Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.