Certification Officer

Sigmar Recruitment

Galway

Certification Officer. Working with Irish and multinational various medical device, especially orthopaedics, companies on certification and auditing. This will report into the European Operations Manager and have huge influence in compliance and certification for medical device companies. Responsibilities. Work on registration, surveillance and recertificationfor clients, assessing the conformance of their QMS covering various medical device facilities, technologies and product types. Conduct audits for the QMS, perform technical reviews and ensure all sites are up to required standards and regulations. Review technical documentation for audits. Ensure you are fully are of developments in global technology and regulatory trends. Work with clients on queries and support for audits, ensuring they are made aware of any updates or added requirements for certification and compliance purposes. Requirements. Third level degree with five years’ experience in the medical device industry. Must have experience in MDD, IVD, TSE and ISO13485 guidelines and regulations. Should have a good understanding of European and international regulations in the medical device sector. Should have orthopaedic device knowledge. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website. This job originally appeared on RecruitIreland.com.

1920 days ago