Quality Systems Engineer
Galway Municipal District - This Area Only
Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485:2016, MDSAP and FDA requirements. The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.
In the absence of the Senior Quality systems engineer the QS Engineer will report to the QA/RA Director.
•Coordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.
•Lead preparation and coordination activities for external audits and liaise as required with SMEs to ensure audits are conducted in an efficient manner.
•Co-ordinate the Document Control Function in conjunction with the appropriate resources.
•Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.
•Coordinate the complaints system to ensure that all complaints are completed in a thorough and timely manner.
•Co-ordinate quality system review activities and reporting.
•Promotes the awareness of regulatory and customer requirements throughout the organization.
•Supports Quality training on site.
•Methodical review approach and be capable of initiating and leading change and continuous improvement.
•Manage the Environmental Monitoring process and system for the manufacturing area etc.
A degree in Engineering, Technology, or Science
•At least 3-5 years experience working in a regulated medical device or pharmaceutical company.
•Excellent planning and coordination skills.
•Excellent verbal and written communication skills.
•Excellent attention to detail skills.
•Ability to work within a team environment to achieve agreed company goals.
•Ability to communicate quality / regulatory concepts effectively.
•Excellent understanding of EN ISO 13485:2016, MDSAP ad FDA regulations.
•Formal Audit Training
•Proficiency in use of desktop software applications such as MS office.
•Some travel may be required with the role.
Environmental Conditions:Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.
Posted 20 days ago