Quality Engineering Professional
The main function of this role is to provide quality engineering support to various teams. This includes providing support for process validation, change requests, non-conforming product issues, and corrective and preventive action initiatives.
Key Responsibilities
* Review and understand validation documentation, change requests, design and process FMEA's, test summaries, software validation, microbiological assessments, and critical system work orders.
* Provide quality engineering support to research and development, sustaining engineering, and production departments up to transfer to production.
* Liaise with production and quality control by providing quality engineering support to incoming quality control, in-process, and final quality control.
* Support supplier appraisal and approval processes.
* Conduct complaint investigations, document findings, and review results.
* Risk assess customer complaints, non-conformances, and CAPA's.
* Provide quality engineering support to the company's Europe quality system.
This role requires a strong understanding of ISO 13485, ISO 14971, the Medical Device Directive, EU Medical Device Regulation 2017/745, and FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.
Required Skills and Qualifications
* Third-level qualification in science, engineering, or a relevant technical discipline.
* Proven knowledge and experience (ideally minimum 4 years) of working with ISO 13485, ISO 14971, the Medical Device Directive, EU Medical Device Regulation 2017/745, and FDA QSR.
This role offers the opportunity to work in a dynamic environment and contribute to the success of the organization.
Benefits
Competitive compensation and benefits package available.
Join Our Team
Apply now to become part of our team.