Senior Quality Engineer
Life Science Recruitment
- Dublin
- Permanent
- Full-time
- Management of the Design Control Process from a Quality perspective and provide assistance and guidance to the Design and Development Team on all aspects of Design Control Documentation.
- Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations.
- Have the responsibility and authority to make decisions related to product quality including the disposition of non-conforming product.
- Demonstrate and actively promote highest level of professional QA Engineering discipline and rigor.
- Be a leader in QSR, ISO/MDR standards and be constantly aware of best industry practices.
- Have some expertise in regulatory requirements.
- Review and approve operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
- Champion continuous improvement and innovation from a quality perspective within the department from vendor selection through to management of outsourced processes.
- Be an effective team member, be fully motivated to achieve and demonstrate best practices in line with the department.
- Provide Training to all personnel on the Quality Management System.
- Build quality into all aspects of work by maintaining compliance to all quality requirements.
- Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.
- A minimum of 5 years’ experience in a similar role (Highly regulated environment)
- Proven track record in leading quality within a medical device manufacturing company.
- Ability to manage quality related projects.
- Proven track record in people management.
- Team player with strong work ethic and positive mentality.
- Thorough knowledge of applicable regulatory requirements (ISO 13485, FDA 21 CFR 820, etc.)
- Excellent communication skills both verbal and written.
- Excellent attention to detail.