Senior Quality Systems Engineer with experience of Quality system Management and development within a regulated environment. This role can be based in Galway or Shannon.
This is a permanent opportunity., Medical Devices experience is ideal for this manufacturing opportunity
- Developing and implementing processes, procedures and instruction to sustain and improve the Quality Management System.
- Supporting Top Management in the development and implementation of quality systems strategies and objectives.
- Preparing the site to host external Regulatory and Corporate audits and demonstrating compliance.
- Coaching and mentoring the organization in working within a medical device Quality Management System
- Working with suppliers, manufacturing, engineering, and other functional areas to assist and verify the implementation and effectiveness of the corrective/preventive actions taken for nonconformance
- Working within a cross-site team to implement best practices in methods and systems that drive Quality Excellence
- Conducting audits and assessments of internal processes and suppliers manufacturing sites
- Provide leadership and guidance within the Quality Systems team on best practice
Expected Areas of Competence (i.e. KSAs)
- Must be familiar with all aspects and elements of a quality system, in particular ISO13485 and FDA QSR.
- Must have experience of hosting audits from external regulatory agencies and corporate functions.
- Experience for leading cross-functional teams would be a benefit.
- Demonstrates ownership for the integrity of work
- Able to work independently and consider options for completing work
- Strong written and verbal communication skills