Quality Engineer position in Co.Meath

Flexsource 83 Merrion Square Dublin 2, Ireland.

Quality Engineer wanted for a Permanent psotion based in Co.Meath, this position will be responsible for maintaining quality standards and ensuring reglatory requirements are met. Generate and maintain technical files and all other relevant documentation required to comply with the Medical Device Directive 93/42/EEC and its relevant national transpositions and any other national or international regulations which apply.
To correspond / communicate with auditing bodies and regulatory authorities in all relevant matters.
To promptly reply to customer queries in relation to quality, technical and regulatory information for products manufactured & distributed.
To liaise with the relevant component authorities and notified bodies of incidents and Field safety corrective action. Execution of field safety corrective actions.
To have the responsibility for developing and maintaining the risk management process in compliance to ISO 14971.
Assist with the overall compliance to the quality system.
Assist in the analysis of quality systems with the intention of designing, promoting and implementing systems and processes for continuous improvement and customer satisfaction.

Educated to degree or equivalent level in a Quality or Scientific discipline.
Must have experience in a Quality Assurance or Microbiology role within a medical device company or Pharmaceutical field.

Must have a flexible approach to work and be capable of handling multiple priorities in a fast paced environment.

Strong attention to detail with a high degree of accuracy and excellent organizational and communication skills.

Contact Michelle.gallagher@flexsource.ie