Software Quality Lead
Kilkenny
€80-85k
€80-85k
Overview:
To support the development and onward growth of our Client's Kilkenny site, we have an exciting opportunity for a Software Quality Lead to join the team. In this role you can grow your career as you help shape the future of healthcare.
It will be a very big plus if you can bring experience in developing projects or sites from square one.
Leading a small specialist team, you will contribute towards ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance through the effective oversight and management of Software Quality Lead. You will take responsibility of implementing Quality objectives and ensuring short term and long term quality goals are met.
It's an exciting time to join, and no two days will be the same, however you will typically:
To support the development and onward growth of our Client's Kilkenny site, we have an exciting opportunity for a Software Quality Lead to join the team. In this role you can grow your career as you help shape the future of healthcare.
It will be a very big plus if you can bring experience in developing projects or sites from square one.
Leading a small specialist team, you will contribute towards ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance through the effective oversight and management of Software Quality Lead. You will take responsibility of implementing Quality objectives and ensuring short term and long term quality goals are met.
It's an exciting time to join, and no two days will be the same, however you will typically:
- Assist in the development & implementation of software systems & policy compliance to regulatory requirements including, FDA QSRs, ISO13485 & IVDD.
- CSV subject matter expert to ensure compliance with GMP, and Data Integrity requirements on all systems.
- Lead the team responsible for the validation and verification of computerised systems
- Collaborate and support digital and data analytics projects.
- Communicate clearly to stakeholders regarding active risk management and problem solving
- Champion training and development of team.
- Ensure validation and qualification activities of processes, methods, and equipment comply with internal requirements and applicable regulations and standards.
- Experience, and understanding of Software Change Control
- Analyse quality and process data using statistical techniques to identify trends and implement improvement plans accordingly.
- Develop key metrics/indicators to track performance and compliance and analyse data to develop and implement improvements.
- Analyse and implement corrective action in relation to non-conformance
- 3rd Level Degree in an Engineering, Computer Systems or Science discipline.
- A minimum of 5 years experience in full Software Lifecyle activities / SDLC, CAPA systems, ALCOA Principles, and leading on quality software projects ideally in Medical Device or Pharmaceutical manufacturing
- Proficient Microsoft office suite
- Strong problem solving and analysis skills
- Proven presentation experience
