Quality Engineer
The role involves partnering with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products, methodologies, processes, and departmental interfaces. This will involve working within the organisation to build, motivate and lead high performance teams.
Responsibilities:
* You will be part of a highly motivated team of Post Market Engineers within the Coronary/RDN Design Assurance function.
* You will provide Design Assurance support to various OU Sustaining & product Surveillance initiatives.
* You will help drive Engagement & mindfulness initiatives ensuring the wellbeing of yourself and your colleagues.
* You will contribute to establishing best practice in accordance with ISO13485/14971, 21 CFR and Corporate Quality standards and Regulatory requirements.
* You will contribute to establishing strong working cross-functional relationships across the organization and with partners within a complex technical environment.
* You will engage with risk management teams consisting of matrixed resources by providing focused technical guidance.
* You will represent the CRDN Post Market department in supporting internal and external audits (MDR/MDSAP/FDA etc.).
* You will contribute to the continuous improvement strategies.
Key Skills & Experience:
* We are looking for a qualified person with a minimum of a Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science) and preferably with a minimum 4 years relevant experience.
* You are a dynamic team player, able to work effectively and proactively on cross-functional teams.
* You can initiate and lead Change, collaborate and create alignment, drive accountability, think critically and make sound decisions.
* You are a good communicator and fluent in English, both in writing and speaking.
* Experience in some form of technical writing is beneficial.
* A working knowledge of Regulatory Standards as applicable.
* Some formal knowledge of Complaint trending or Post Market Surveillance would be considered beneficial.