For our client, a leading global medical device manufacturer, we are seeking a Quality Engineer to join a dynamic New Product Development site in Galway, Ireland. This is a unique opportunity to play a pivotal role in the development and production of innovative medical devices.
This is a multi-functional, hands-on role, ideal for someone who thrives in a dynamic environment where responsibilities span across the Quality Management System (QMS), elements of Quality Control (QC), and cross-functional engineering support. Given the lean nature of the site, the successful candidate will be a key contributor across various quality and operational areas.
Please note that the role requires daily on-site presence.
Key Responsibilities:
* Oversee and support daily quality activities on the production floor
* Maintain and improve the Quality Management System (QMS) in line with ISO 13485
* Conduct internal audits and identify areas for improvement
* Lead investigations, root cause analysis, and implement CAPAs
* Review and approve DHRs, validation protocols, and change controls
* Support risk assessments and product risk management activities
* Manage supplier quality and conduct supplier audits
* Train and support teams on quality standards and best practices
* Monitor key quality metrics and report performance
* Ensure quality is integrated throughout product development
* Support audit readiness and regulatory inspections
Requirements:
* Proven experience in quality engineering in a medical device manufacturing environment
* Experience working with Quality Management Systems (QMS) and standards such as ISO 13485 and FDA regulations
* Strong understanding of quality control principles, statistical analysis, and root cause analysis techniques
* Experience with internal and external audits
* Experience working in small or fast-paced environments
* Strong hands-on experience with V&V
* Ability to work independently and take ownership of quality processes
* Skilled in coaching and guiding production teams
* Excellent documentation and communication skills
* Flexible, hands-on, practical, and comfortable with cross-functional tasks
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