Job Title: Senior Design Quality Engineer
We are seeking a highly experienced Senior Design Quality Engineer to join our team in Galway. This is a full-time, hybrid role on an initial 9-month contract.
Role Overview
* Provide QA technical and compliance expertise as part of teams establishing customer needs, developing new products, and modifying existing designs.
* Ensure Design control and Risk Management activities are completed.
* Offer quality support and guidance to R&D project leads and team members.
* Direct and support Design Assurance engineers and Quality Engineers.
* Coordinate Design Assurance Engineer resources to support business objectives.
* Resolve project issues through collaboration with team members, suppliers, and other stakeholders.
* Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Maintain records related to design control projects.
* Contribute to and participate in design review meetings.
Key Responsibilities:
* Develop and implement Design Control processes to ensure regulatory compliance.
* Analyze data to identify trends and areas for improvement in Design Control and Risk Management.
* Collaborate with cross-functional teams to develop and implement effective risk management strategies.
* Maintain accurate and up-to-date records of Design Control activities.
* Provide training and guidance to colleagues on Design Control processes and procedures.
Requirements:
* Bachelor's Degree in Engineering, Biomedical Engineering, Science, or related discipline.
* 5+ years of experience in a similar role.
* Demonstrated knowledge of design control principles, concepts, and practices.
* Experience with preparation, participation, and response to external agency inspections (e.g., FDA and Notified Body Inspections).