Quality Engineer

Finesse Medical Ltd is a Medical Device Manufacturing Company located in Longford town.

As part of the Global Avery Dennison Group, we specialises in the development, manufacture and marketing of  advanced technologies used for the management of a variety of wound and skin conditions.

We would like to invite applications for the post of

Quality Engineer

The successful candidate will form part of an established Quality team and report to the Head of Quality & Regulatory Affairs. Essential duties and responsibilities include:

• Ensure that requirements laid down in the Quality Manual and Standard Operating Procedures and any other company quality documents are adhered to, and provide advice and guidance on quality related aspects.

• Conduct internal audits, including closing out audit findings in a timely manner, creating audits finding reports and determine proper corrective and preventive actions.

• Key member of New Product Introduction team, with responsibilities that include generating quality documentation.

• Generation and management of process deviations, non-conformances, supplier complaints, reworks, CAPA, complaints, rejects and change notices.

• Works with Production to solve in-house quality concerns, reviews of non-conforming product and recommends disposition.

• Create, maintain and issue company quality documentation, such as standard operating procedures.

• Provide training to new and current employees when required.

• It will be also needed to regularly monitor a specific production area to ensure product is manufactured as per the relevant quality documentation.

• Liaise with Suppliers and Customers on quality related issues.

   

Skills and Experience:

• Degree in Quality/ Science or Engineering.

• Minimum 3 years’ experience in a Quality role within a similar

  manufacturing organization.

• High level of computer literacy.

• Good attention to detail and organisational skills.

• Strong written and oral skills.

• Knowledge of and experience with ISO 13485, FDA regulations Part 820, the Medical Device Directive (93/42/EEC), Lean manufacturing and Six Sigma would be an advantage.

• Capable of working in a fast paced environment.

• Experience working in cross functional teams.