Senior Quality Systems Engineer (Digital Health)
Our client, a medical device company in Galway are currently looking to recruit a Senior Quality Systems Engineer (Digital Health) for their site.
- Acting as a quality systems subject matter expert champions digital health/ hospital solutions process development and global continuous improvement activities while ensuring they meet regulatory requirements.
- Must have experience in CAPA - Corrective Action Preventive Action - owning and executing quality system changes.
- Must have good understanding of quality system and how each quality system element connects.
- Responsible for maintenance of Healthcare Solutions Quality Plan.
- Must have experience in working with vendors - understanding what services they are providing and how the service fits into the BSC quality system.
- Provide insight and expertise on quality system processes and to both internal BSC customers as well as working with external partners.
- Must be able to apply project management principles and techniques as they relate to quality system planning, implementation and tracking. Must be able to evaluate and manage risk.
- Facilitates bi-weekly Digital Health & Healthcare Solutions meetings driving actions to conclusion.
- Basic understanding of software validation methodologies is beneficial.
- Basic understanding of product development processes is beneficial.
- Bachelor Degree in the Engineering or Science field, plus 4-6 years of related experience or an equivalent combination of education and work experience
- Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
- Experience with CAPA, Vendor Controls, and External Audits
- Flexible and positive attitude
- Comfortable speaking and presenting to leadership
- Computer literate, network knowledge required
- Good communication skills
- Creative thinking and innovation
- Strong analytical skills
- Project management skills
For further information on this Senior Quality Systems Engineer (Digital Health) role in Galway please contact Bimi Felix on 091730022 / firstname.lastname@example.org
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