Senior QA Engineer
Job ID: JOB-12713
Senior QA Engineer
Working in QA Engineering is in big demand right now. We’re looking to speak with experienced QA Engineers who are looking to work with top global leaders who value their people. This is a great job opportunity in Mayo for a Senior QA Engineer who enjoys working on innovative projects, values autonomy in their job and working in a great team.
Talk with us about this newly created Senior Qa Engineering job opportunity in Mayo to find out more.
The purpose of the position is to represent QA on the NPI program team. Understand interdependences across NPI projects and Continence Care sites, through to distribution and drive appropriate action. In addition support the delivery of Global Quality Strategy at the site
- QA oversight of NPI program through to Production & ramp up of production
- Represent QA at NPI program meeting i.e. QA program update 4-square
- Submit QA update on NPI for Global Quality Regulatory and Clinical monthly meeting
- Understand interdependencies across projects & sites
- Understand & compile a list of QA risks across each project/site
- Work with risk owners on mitigation plan to understand action, timeline, impact to overall project
- Co-ordinate (as required) cross site/program actions
- Initial Point of contact for project Design Assurance/QA and Site Functional Managers for escalation of NPI related quality issues
- Program Lead for delivery of Global Quality Strategy at the Ballina Continence Care site.
- Other responsibilities:
- Complete internal audits per the audit schedule
- Complete CAPA investigations
- Lead audits for the department
- Other duties as required.
Qualifications & Requirements
- Degree in Engineering/Science Discipline and Quality Engineering Qualification
- Experience in statistical analysis / SPC / validation of automated equipment
- 8 years’ experience in Medical Device Industry utilizing automated equipment
- Experience of working cross functionally
- Master’s degree in Engineering/Science Discipline an advantage
- Experience in Project/ Program Management an advantage
- The suitable candidate should have a working knowledge of Design Controls, Design and Process Validation, Process Risk Management, be able to provide QE support for New Product Development (NPD) projects and change controls
- They should also be proficient in working in cross functional teams, be able to coordinate cross functionally and cross site
- Strong communication skills essential
For further information on this role in Mayo please contact Aisling Kidney on 0872197421 or firstname.lastname@example.org
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