Direct message the job poster from Sterling Engineering Ltd - Ireland & Europe
Recruitment Consultant at Sterling Engineering Ltd - Ireland & Europe
Purpose of the Job:
The Senior Quality Engineer is a key member of the Quality and Regulatory department, responsible for ensuring compliance with the Quality Management System (QMS) and supporting site-wide quality initiatives. This role involves guiding QMS integration, driving continuous improvement, and ensuring adherence to documented procedures. The Senior Quality Engineer also provides technical expertise, supports problem-solving efforts, and mentors junior team members. This position is based onsite in Shannon, 5 days per week.
Responsibilities:
* Maintain up-to-date knowledge of internal and external quality system standards and requirements.
* Provide Quality oversight for Design Control Processes, offering guidance on Design and Development documentation, including FMEA, Quality Agreements, and Quality Plans.
* Review and approve operational, test, and validation data to define technical specifications and performance standards for new or modified products and processes. Generate and approve protocols and reports.
* Investigate product quality and compliance issues (e.g., CAPA, non-conformances, audit observations). Use structured problem-solving techniques such as 5 Whys, 8D, and A3 to identify root causes and recommend corrective actions.
* Identify areas of improvement within quality systems and implement corrective and preventive actions to enhance compliance and efficiency.
* Develop and monitor key quality metrics (KPIs), presenting results to stakeholders using professional reporting tools.
* Prepare and maintain records associated with Management Reviews.
* Collaborate with cross-functional teams to drive compliance, providing guidance to update and create quality procedures through the change control process.
* Support and participate in internal and external audits, ensuring compliance with regulatory standards.
* Train and mentor colleagues on QMS processes, including conducting quality inductions for new employees.
* Contribute to site-wide quality improvement initiatives by utilizing Lean and Six Sigma tools, and educate teams on these methodologies.
* Assist with projects to improve product quality, reduce costs, and validate products and processes. Develop and implement new inspection methods and in-process SPC where required.
* Ensure compliance with health and safety policies while maintaining a collaborative and proactive attitude in a fast-paced manufacturing environment.
Required Qualifications:
* Education: Bachelor’s degree in Quality, Engineering, or Science (Master’s degree is an advantage).
* Training: Level 5 or above in training or equivalent qualification.
* Experience: 8-10 years of experience in the medical device industry, including experience with quality systems, complaint management, and CAPA investigations.
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.
For more information and a confidential chat please contact Niall Finnerty on +35386 1980270/ NFinnerty@sterlingengineeringeu.com
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Quality Assurance and Engineering
Industries
* Medical Equipment Manufacturing
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