Our client is a global medical device healthcare solutions company who are committed to improving lives through medical technologies, services, and solutions. They operate across 350 facilities in 150 countries, with an innovative portfolio of over 46,000 patents. They are currently looking for a Senior Quality Engineer - Process Validations.
The Role
This exciting contract role is to provide support as part of a cross-functional team, providing Quality Engineering technical direction/input to the process validation activities post commercialization.
Key Responsibilities would include:
- Provide expert QE technical direction/input to qualification and validation activities in conjunction with Engineering and extended QA teams to ensure quality standards are in place.
- Author and support (input and critical review) of qualification/validation protocols/reports.
- Completes test method validation for methods and procedures used for inspecting, testing and evaluating the precision and accuracy of products, test and production equipment.
- Support the introduction/implementation of process/material changes to the manufacturing operation. You will assess the impact on process validation for these changes.
- Function effectively as part of cross functional teams; develop strong partnering relationships within these groups and provide constructive feedback and quality leadership.
The Person
In order to be considered for this exciting daily rate Senior Quality Engineer role, specific requirements for the successful candidate would include:
- Degree (L8) in Science/Engineering or relevant technical discipline
- 5+ years of relevant work experience
- Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements
What's on offer:
- Exciting long-term daily rate contract role within a leading global healthcare solutions company
- Opportunity to work within a global leader giving you access to build your portfolio within the medical device industry
- Potential for a long term opportunity within the organisation
To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.
