About the Role
We are seeking a Senior Quality Engineer to join our team in Shannon, Ireland. The successful candidate will be a key member of our Quality and Regulatory department, responsible for ensuring the Quality Management System functions are maintained in compliance with documented procedures.
Key Responsibilities:
* Support the QMS integration activity across the site, providing guidance and expertise to ensure on-going compliance and continuous improvement alongside cost reduction.
* 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, analyse data, make recommendations and develop reports and present.
* Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations.
Requirements:
* Excellent written and spoken English, spelling and grammar are key skills.
* Bachelor's Degree in Quality/Engineering/Science, Master's degree an advantage.
* Level 5 or above in training or similar.
* Minimum 8-10 years of experience in Medical Device industry with 3 years of supervisory/leadership experience.
* Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations.
* Lead Auditor qualification or considerable internal audit experience necessary.
Additional Skills:
* Excellent interpersonal, written and verbal communication skills.
* Pro-active attitude, excellent organisation skills, and ability to manage multiple projects while delivering results on time.
* Experience of Cleanroom technology, SMT, PTH and IPC standards.
* Familiar with use of online Quality Systems; QT9 a distinct advantage.