A leading Medical Device organisation is seeking a Senior Quality Engineer to join their business permanently. The Sr. Quality Engineer will be expected to provide support to Global Sites whilst being based full-time in Galway. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, fast-paced environment. You will be reporting directly to the Quality Director.
Key Requirements (full spec available on request)
- Supporting global sites whilst based full-time in Galway (up to 5% travel required)
- Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus.
- Actively participates in internal audits, management review and other activities covered
- Provide customer-related quality and regulatory inquiries support.
- Compiles and writes training material and conducts training sessions on quality control activities
- Lead and provide Project Management support as needed.
- Lead supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA.
- Direct support for FDA and ISO inspections and registration.
- Process improvements.
What you need to have
- Level 8 in either Science or Engineering is required.
- 8 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility.
- Experience with FDA and ISO 13485 Certification inspections is a plus.
- Audit experience, strong project management skills and continuous improvement experience is essential for this role.
- Must be adept in the use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred).
- Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.
- Must possess excellent verbal & written communication skills, which include but are not limited to, presentation, organizational and management skills.
- Annual bonus
For a confidential discussion and more information on the role, please contact Elaine Dolan.