Senior Quality Engineer - Process Validation - Hybrid
Job description
Medtronic
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations
Our Purpose
At our Process Validation department in Medtronic, plc, we focus on providing process validation support throughout the full lifecycle of the product. From initial development of new products to ongoing support when products have been commercialized, we ensure that the performance and safety of the devices we support is maintained through the product lifecycle.
Come for a job, stay for a career!
- Work on New Product Development supporting the Coronary Division as part of a cross-functional team. Provide Quality Engineering technical direction/input to process development.
- Provide expert QE technical direction/input to qualification and validation activities in conjunction with Design, Engineering, and extended QA teams.
- Manage and mentor other process validation engineers as required.
- Author and support (input and critical review) of qualification/validation protocols/reports.
- 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.
- Support the introduction/implementation of process/materials changes to the manufacturing operation. Assess the impact on process validation for these changes.
- Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.
- We are looking for a person 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 working in the medical device or other regulated industry.
- Experience of process validation activities in medical device or other regulated industry.
- Be focused on patient and customer, set high standards and instill operational excellence.
- Practical working knowledge of statistical data analysis, problem solving.
- and quality improvement tools and techniques preferable.
- Dynamic team player and can work effectively and proactively on cross-functional teams.
- Knowledge of regulatory requirements and guidelines is an advantage.
- Knowledge of statistical requirements and software validation requirements is an advantage.
- Good communicator and fluent in English, both in writing and speaking.
- Good organizational, presentation and project management skills are desirable.
Medtronic offer a competitive salary and flexible Benefits Package.
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