Job Description

Quality Engineer - County Wexford

Ref No: AM17536

Wexford, Co. Wexford, Ireland

Competitive salary

Quality Engineer - County Wexford.

 We are looking for an experienced Quality Engineer with New Product Introduction experience for this state-of-the-art manufacturing facility in County Wexford. In this role you 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 non-conformances.
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.

Interested applicants should be technically qualified with a bachelor’s degree, preferably in an Engineering, Technical or Science discipline.

The ideal candidate will have a minimum of 4 to 5 years' experience in the Medical Device or Pharmaceutical industry, and will have knowledge of quality management systems ISO 13485, GMP etc.


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