Responsibilities may include the following and other duties may be assigned:
* At the appropriate point during post commercialization, work to ensure a smooth transition of product Quality responsibilities from DAE to the Post Market Product Assurance group (reliability/performance metrics reporting, etc.).
* Prioritize timely completion of complaint investigations, CAPA decisions, and DHR reviews, ensuring that corrective action decisions and investigations are based on sound engineering analysis and review.
* Develop and maintain a robust process for identifying and monitoring root cause failure mode`s, frequency, and severity. Provide statistical data to QA and management on product performance, effectively describing clinical observations and the relationship with device performance.
* Represent QA in product Risk Analysis updates for assigned products.
* Collaborate with returned product analysis lab to derive root cause and lead failure investigation activities for returned products.
* Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvements.
Key skills and experience:
* We are looking for a qualified person 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 2-3 years relevant experience.
* Established and productive individual contributor.
* You are a dynamic team player, can work effectively and proactively on cross-functional teams.
* Sets objectives for own job area to meet the objectives of projects and assignments.
* You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
* You are experienced to a competent level within Medical Device Design.
* Excellent communication and ability to influence is critical to the role. You must be fluent in English, both in writing and speaking.
If you would like to hear a little bit more about it, please email me your CV to [email protected] or apply in the link below.
