Senior Quality Engineer

Desired Skills: quality,operations,GMP

The role:

PE Global is currently recruiting for a Senior Quality Engineer on behalf of a leading medical device company based in Galway. This is an initial 12-month contract role.

Description:

In our Coronary/RDN Post Market Design Assurance Department, we focus on partnering with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products, methodologies, processes, and departmental interfaces, while working within the organisation to build, motivate and lead high performance teams.

Responsibilities:

• You will be joining 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 & mind fullness 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.

Education & 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, Mechatronics, Science) and desirably with a minimum 4 years relevant experience.
• You are a dynamic team player, can 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 beneficial.
• A working knowledge of Regulatory Standards as applicable.
• Some formal knowledge of Complaint trending or Post Market Surveillance would be considered beneficial.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***