Job Title: Quality Engineer
Kelly Services have partnered with an exciting new client in the Galway area. They are looking for a Quality Engineer to join their expanding Medical Device company on a permanent basis.
The Quality Engineer will manage key elements of the Quality System to ensure compliance to relevant standards for the business. 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.
- 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
- Coordinate 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 Non-Conforming and CAPA system to ensure that all NC/ CAPAs are completed in a thorough and timely manner
- Assist with Management review planning and execution
- 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
- Other project work as assigned by the Quality Systems Manager
- Familiar with relevant standards including EN ISOI 3485:2016, MDSAP and FDA requirements
- At least 3-5 years’ experience working in a regulated medical device or pharmaceutical company
- Excellent verbal and written communication skills
- Excellent planning and coordination skills
- Excellent attention to detail
- Ability to work within a team environment to achieve agreed company goals
- Ability to communicate quality/ regulatory concepts effectively
- Excellent understanding of EN ISO , MDSAP and FDA regulations
- Formal Audit Training
- Proficiency in use of desktop software applications such as MS office
- Some travel may be required with the role
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly’s Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.