Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient outcomes and create value for customers and employees.
We have an exceptional opportunity for a Senior Supervisor, Design Quality Assurance, to join our expanding team. In this key role, you will demonstrate commitment to quality by executing sound quality practices and maintaining an effective quality system.
The Design Quality Assurance team supports a wide product portfolio, including drug eluting therapies, balloon dilatation catheters, and cutting balloons for Interventional Cardiology. As a successful candidate, you will lead projects related to the balloon catheter product family, providing supervision and coaching to a minimum of 3 engineers within your reporting structure.
Your key responsibilities will include:
* In-depth understanding of requirements and procedures governing medical device Design Control.
* Leading design change projects, including scoping, assessment, and implementation.
* Ensuring regulatory compliance with company SOP/WI's and EU/FDA/Global guidelines.
* Providing support and direction for post-market surveillance activities, such as Field Signal Evaluations and Periodic Safety Update Reports (PSURs).
To be considered for this role, you must possess:
* NFQ Level 8 qualification in a STEM discipline.
* Minimum 6 years' industry experience; Design Assurance experience preferred.
* Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills.
This is an exciting opportunity for a motivated individual who is enthusiastic about developing their career and driving improvements in product and process quality.