A brand new role has come to the Galway market with one of our key clients.
The Global Design Assurance Manager has the responsibility to assure the quality of product design from development through manufacture and commercial distribution for all new and upgrade products developed within this specific business unit. The role must develop and deliver a robust system of Design Controls and build a talented team of design quality professionals that can work effectively with the R&D and Regulatory functions to execute design excellence. The Design Assurance Manager is responsible to develop and implement a design quality strategy that supports the overall quality strategy as well as the key business goals.
Key Duties (full spec available on request)
- Responsible for implementing and maintaining the effectiveness of the Design Controls system across Manufacturing plants
- Provide design assurance oversight to all functions operating in the New Product Introduction area.
- Ensure timely communication with VP of QA and Senior Leaders on critical design quality issues that arise at any stage of the product design process.
- Pro-actively monitor Post Market surveillance trends to ensure any potential design issues are addressed as well as developing a closed-loop feedback system to the design process.
- Work closely with the R&D and Design Quality teams to ensure robust new product launch planning and successful design transfer process.
- Bachelor’s Degree – Engineering/Science/Life Sciences – Postgraduate degree desirable.
- The job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast-moving R&D environment.
- Experience managing a design assurance team is essential and preferably experience working with teams remotely.
- Proven track record in delivering successful NPI programs on budget and on time and continuous improvement programs.
- 5 years plus experience in a QA/R&D or another Technical leadership role in a regulated environment
What you will receive in return
- Competitive salary DOE
- Full healthcare
- Life Assurance
Please contact Elaine Dolan for more information on;
091 706 718