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 an experienced Senior Quality Engineer within the Process Validation Department to lead the validation requirements for a product transfer to the site providing input to process development and process validation.
This exciting long-term contract role is within the Process Validation Department, the focus is on providing process validation support during the full lifecycle of the product. From initial development of new products to line transfers to ongoing support when products have been commercialised to ensure that the performance and safety of the devices they support are maintained through the product lifecycle. The position is intended to be a long-term interim position.
Key Responsibilities would include:
- Working as part of a cross-functional team, providing expert Quality Engineering technical direction and input to qualification and validation activities in conjunction with Engineering and extended QA teams.
- Author and support (input and critical review) of qualification/validation protocols/reports.
- 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.
- Understand product construction, features and uses at a highly competent level to contribute to decision making process on product acceptance standards within their scope of responsibility.
- Lead or support root cause investigations; drive problem solving efforts for quality issues.
- Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.
In order to be considered for this exciting daily rate Senior Quality Engineer role, specific requirements for the successful candidate would include:
- Qualified to Minimum of a Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 5 years relevant experience.
- Experience within the Medical Device sector
- Knowledge of regulatory requirements and guidelines including 21 CFR part 820, MDR and ISO 13485 requirements is necessary.
- Knowledge of statistical requirements or software validation requirements an advantage.
- You are a good communicator and fluent in English, both in writing and speaking.
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.