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 QMSLead QMS continuous improvement activitiesEnsure delivery of overall quality strategy & support achievement of the business quality objectivesCollaborate with wider team to ensure necessary QA activities are planned, executed and documentedInterpret relevant standards and ensure company meets requirementsDevelop and review test specifications, part specifications & design specifications with cross functional teamSupport manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification, process validation and change controlProvide practical QA and Design Assurance expertiseSupport supply chain in supplier related activities e.g. process development and manufacturing requirementsCoordinate and manage key activities such as internal audit programme, material review board, NC/CAPA review board, complaint processProject support for regulatory submissionsSupport clinical investigations
Qualifications:
Bachelor's Degree in Engineering, Science or related field3+ years' experience in medical device quality/design assurance roleRecent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive and other applicable national and international regulations and standards
Desirable:
Master's degree in Engineering, Science or related fieldExperience in implantable medical devicesExperience with process development and change management in regulated environment
Does this sound like your next career move?
To apply, forward your application to the link provided or contact me on 0870608656 OR