Telephone: 086 8395533
Senior Quality System Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Quality System Engineer for their site.
- Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485, FDA QSR.
- 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.
- Also work with the R&D team and being responsible for Medical Product (CE Mark and FDA 510k) Design Assurance and Risk Management Activities on individual projects that are assigned.
- 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 SME’s to ensure audits are conducted in an efficient manner.
- Manage all aspects of 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.
- Identifies any opportunities for improvement within the quality system procedures and practices in association with the appropriate internal groups.
- 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.
- A degree in Engineering, Technology, or Science
- At least 7 years’ experience working in a regulated device or pharmaceutical company.
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills
- Previous experience in leading or participating in external notified body or regulatory audits.
- Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.
For further information on this Senior Quality System Engineer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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