Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

At the Enniscorthy facility, we manufacture mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries. We are looking for an experienced Quality Engineer with New Product Introduction experience for our state of the art facility in Enniscorthy. The Quality Engineer will assure that new products and the processes for manufacturing them meet all local, Corporate and Divisional requirements with respect to safety and efficacy.

Main responsibilities will include:

• Represents quality interests and concerns on project teams.
• Leads risk management activities and leads the Quality engineering activities for NPI projects.
• Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance.
• Develops or assists in development of inspection and test methods per product specifications.
• Performs test method validations and component qualifications as required
• Performs DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation.
• Identifies quality systems engineering improvement opportunities and executes through the change management system
• Participates in internal audit and supplier audit programmes
• Participates on teams responsible for investigating and providing corrective action for production and supplier nonconformances.
• Develops robust action plans, projects and verification activities for elimination of potential at compliance and CAPA related risks, as required
• Assists in the Company’s complaint and failure investigation process.

You will be technically qualified with a bachelor’s degree, preferably in an Engineering, Technical or Science discipline.

The ideal candidate will have a minimum of 5 years’ experience in the Medical Device or Pharmaceutical industry. Also, it would be beneficial some knowledge of quality management systems ISO 13485, GMP etc.

You will have excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines coupled together with problem solving techniques with excellent organizational skills. Dedication to excellence, flexibility and adaptability to change are also a plus.