What you need to know:
A manufacturing engineering company in Galway are looking for a Senior Validation Engineer to join their team. This is a fantastic opportunity to join the global leader in medical technologies. This is an 18 month contract in which you will gain valuable experience in the medical device industry.
Your new job:
As a Senior Validation Engineer you will work lead a team and validation requirements for a product transfer to the Galwaty site. Responsibilities include:
- You will provide input to process development and process validation.
- You will work as part of a cross-functional team, providing expert Quality Engineering technical direction and input to qualification and validation activities
- You will support the introduction/implementation of process/material changes to the manufacturing operation.
- You will author and support (input and critical review) of qualification/validation protocols/reports.
- You will have the ability to function effectively as part of cross functional teams; develop strong partnering relationships within these groups and provide constructive feedback and quality leadership.
- You will understand product construction, features and uses at a highly competent level
- You will lead or support root cause investigations; drive problem solving efforts for quality issues.
What are we looking for?
- Have a bachelor/Masters Degree level in Mechanical, Biomedical or related engineering/ science discipline.
- Have 5 years relevant industry experience.
- Be a team player, can work effectively and proactively on cross-functional teams.
- Have knowledge of regulatory requirements and guidelines including 21 CFR part 820, MDR and ISO 13485 requirements
- Have knowledge of statistical requirements or software validation requirements
- You will be an experienced decision maker on validation strategies and be able to provide status updates and escalate issues when necessary.
Apply for this job now or get in touch with Jack Linnane on 09064 90485.
We Value Your Trust.