Senior Quality Engineer - Process Valida

SIGMAR RECRUITMENT

GALWAY

Senior Quality Engineer - Process Validation. Work on a major tech transfer stemming from an acquisition at the excellence and innovation hub for a MedTech multinational. The aim for this project is to replicate the manufacturing onsite across process characterisation, verification, validation and equipment validation. The focus of this role and department is on providing process validation support during the full lifecycle of the product. Responsibilities: Act as the lead and key decision maker for process validation during a product transfer to this Galway site. Work cross functionally with Quality and Manufacturing functions, managing Process Verification and Validation. Author and support (input and critical review) of qualification/validation protocols/reports. Support the introduction/implementation of process/material changes to the manufacturing operation. You will assess the impact on process validation for these changes. Lead or support root cause investigations; drive problem solving efforts for quality issues. Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics. Requirements: Must come from a medical device manufacturing background with 5 years or more working on process validation. Must have a University level degree. Ideally would have exposure to Polymer, Plastics or Soldering exposure. 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.

1485 days ago