SENIOR QUALITY MANAGER
The successful candidate will own the Quality Systems and collaborate with cross-functional teams to transition new medical device products into international markets.
Capri-medical is a start-up Medical Device company located in Dublin, Ireland. We create BioElectronics devices which modulate the peripheral nervous system in order to address many of the world’s most pressing healthcare needs. Our purpose is to enable the universality of BioElectronics devices in healthcare treatments.
Capri-Medical was ranked second in Europe’s flagship EIC program which funds Europe’s most promising startups. We’re looking for talented individuals who thrive in a culture of innovation and empowerment and who are active learners and have a positive attitude. By doing so, we will continue to set new standards in health care.
About the Role:
The role will involve overall management of Capri-Medical’s QMS (Quality Management System) for the development of implantable electronics and controller devices.
Set up and ensure compliance to Company Quality Management System, and relevant Regulations and International Standards.
Establish and maintain Design History File contents and associated activity plans and timelines
Support Risk Management activities for development programs through the implementation of EN / ISO
Setup and maintain ISO Quality Management System certification including adherence to relevant Regulatory requirements e.g. 21 CFR 820, Medical Device Directive (93/42/EEC), Medical Device Regulation (2017/45).
Participate in external audits - Health Authority Audits, Certification Body audits.
Establish and rollout best practice training to personnel to ensure compliance with quality systems
Maintain awareness of ongoing industry best practices
Support clinical and regulatory submissions as required
Degree in BioMedical Engineering or relevant field
8+ years of relevant quality management experience
Experience in electronic implantable products
Experience in transitioning new products to market
Experience in full lifecycle development
Key Candidate Attributes:
Able to work independently and as part of a team
Innovative thought process
Competitive salary, Share Options, Performance Bonus,