Senior Quality Engineer Role
The Senior Quality Engineer is a key member of the Quality and Regulatory department at our Shannon-based Medical Devices Client. This role plays a vital part in ensuring the Quality Management System functions are maintained in compliance with documented procedures.
Responsibilities:
* Assist or supervise other Quality Engineers, technicians, and administrative personnel in the performance of their duties.
* Support the QMS integration activity across the site, providing guidance and expertise to ensure ongoing compliance and continuous improvement alongside cost reduction.
* Stay current with external and internal quality systems standards and requirements.
* Manage the Design Control Process from a Quality perspective and provide assistance and guidance to the Design and Development Team on all aspects of Design Control Documentation.
* Review and approve operational, test, and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
* Investigate complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations), analyze data, make recommendations, and develop reports and present.
* Apply problem-solving skills creatively to deal with complex situations.
* Identify problems and possible solutions and take appropriate action to resolve.
* Drive compliance cross-functionally and mentor and guide other departments where necessary.
* Participate and support internal and external audits.
* Train, coach, and guide colleagues on all aspects of Quality Management Systems.
Requirements:
* Excellent written and spoken English, spelling, and grammar are key skills.
* Bachelor's Degree in Quality/Engineering/Science; Master's degree is an advantage.
* Level 5 or above in training or similar.
* Minimum 8-10 years of experience in the Medical Device industry with 3 years of supervisory/leadership experience.
* Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations.
* Experience with complaint management (reporting), problem-solving, and CAPA investigations - Regulatory experience regarding same and/or qualification in related fields.
* Lead Auditor qualification or considerable internal audit experience necessary.