Job Title: Senior Quality Engineer
Location:Glasnevin, Dublin 11

Company:
My client are a Dublin-based medical device company specialising in innovative heart failure management solutions. Founded in 2013, the company is dedicated to improving outcomes for individuals suffering from chronic heart conditions through advanced remote monitoring technologies.

Overview:
To drive the day to day implementation of the QMS with a focus on continuous improvement. Support manufacturing, supply chain and design assurance activities. Represent the quality function cross functionally.

Responsibilities:

• Drive the day to day implementation of the QMS
• Lead QMS continuous improvement activities
• Ensure delivery of overall quality strategy & support achievement of the business quality objectives
• Collaborate with wider team to ensure necessary QA activities are planned, executed and documented
• Interpret relevant standards and ensure company meets requirements
• Develop and review test specifications, part specifications & design specifications with cross functional team
• Support manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification, process validation and change control
• Provide practical QA and Design Assurance expertise
• Support supply chain in supplier related activities e.g. process development and manufacturing requirements
• Coordinate and manage key activities such as internal audit programme, material review board, NC/CAPA review board, complaint process
• Project support for regulatory submissions
• Support clinical investigations

• Bachelor’s Degree in Engineering, Science or related field
• 3+ years’ experience in medical device quality/design assurance role
• Recent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive and other applicable national and international regulations and standards

• Master’s degree in Engineering, Science or related field
• Experience in implantable medical devices
• Experience with process development and change management in regulated environment