Position: Quality Systems Engineer
Location: Oranmore, Galway
Benefits: Excellent salary, pension, healthcare and yearly bonus.
Company: Orthopaedic multinational
The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will entail directing and/or supporting the Quality Management System processes, including but not limited to Corrective and Preventive Action, Internal and External Audits, Quality Trending and Quality Management Review
- You willeffective implementation of the Quality Management System (QMS) throughout the organization, including completing gap assessment and closure for any regulatory changes that have impact on the quality management system.
- Maintains the site Quality Manual and Quality Systems Procedures and ensure contents are aligned to the Global Zimmer Biomet process and applicable regulations/standards
- quality trending process for determining the effectiveness of applicable quality systems, develop processes and plans to address improvements as identified.
- Support site internal audit program, including conducting internal audits and ensuring that audits are completed on time and in full and that all observations are being addressed by owners as appropriate.
- Must be familiar with all aspects and elements of a quality system including but not limited to management responsibility, and measurement, analysis and improvement processes.
- Strong knowledge and understanding of 21 CFR 820, ISO 13485 and regulatory requirements applicable to the QMS.
- Qualified Auditor to 21 CFR 820 or ISO 13485/9001 (IRCA Accredited Lead Auditor qualification desirable).
- Bachelor's degree in Engineering, Technology or Science is required or an alternative Bachelor's degree with certification as a Quality Engineer (e.g. CQE)
- Must be familiar with Microsoft Office Suite
- Must have minimum of 3 years of experience in Quality Engineering field
If you are interested in discussing this position and others like it forward me your up to date CV or contact details provided for more info. Stay safe and looking forward to speaking with you
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales