Join the Quality team and work to ensure that the company's Quality Assurance responsibilities are fulfilled.
- Lead risk management process in compliance with EN ISO 14971 and preparation of risk management files and FMEAs.
- Compilation and execution of Process Validation Protocols in line with manufacturing.
- Support Supplier Qualification, Assessment and Audit process at key Suppliers.
- Establish and maintain incoming, in-process & final inspections requirements and support design and validation test requirements as required.
- Generates NCRs and CAPAs for defects and ncr's and follow up to ensure effective closure.
- Responsible for sterilization evaluation documentation and product release.
- Support calibration and maintenance programs.
- Manage validation and monitoring in relation to particulate and biocontamination control.
- Work directly with all departments (including Production, Design & Regulatory) on product development, transfer and improvement projects.
- Supports the design verification process.
- Support QMS activities including internal audits.
Essential Skills, Qualifications & Experience:
- Degree in Biomedical engineering/science discipline or Quality Management together with experience in an engineering function, preferably within a medical device or related industry.
- 2+ years’ experience as a Quality Engineer or within a similar role within medical devices.
- Strong technical and analytical problem-solving abilites.
- Knowledge of Medical Device Quality Management System Requirements ISO 13485, MDD 93/42 EEC, 21 CFR Part 820, CMDR.
- Ability to work independently and as part of a team within a fast-paced environment.
Desirable Skills & Experience:
- Experience or training in; Validation, Biocompatibility, Ethylene Oxide sterilization or microbiology.
- Medical Device Design or Quality Assurance experience.
- Familiarity with Gamp 5 or computer systems validation.
To apply for this position please contact Keeva O’Shea at Sigmar Recruitment Tel: +353 91 749264 Email: email@example.com
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.