Quality & Regulatory Affairs (QA/RA) Engineer

What’s important:

• Working experience of a certified Quality Management System
• Training as an internal Auditor
• Root Cause Corrective Action Analysis and CAPA management
• Complaints handling
• Document control and engineering change management experience
• Knowledge of regulatory processes for EU and FDA product clearance

The day to day:

• Support the VP of Quality in managing the Document Control process and the internal audit process.
• Support the VP of Quality in managing the CAPA process.
• Support the Quality Management process.
• Generate and share reports on relevant quality metrics.
• Complete internal audits as required.
• Support regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
• Support the VP of Quality in managing the Risk Management process for all existing and new products.
• Maintain technical files for all cleared products.
• Complaints handling for medical reporting and filing to the appropriate competent authorities.
• Keep up to date with changing regulatory and compliance requirements e.g. REACH ROHS2 etc.

Where you’ve come from:

• You will have a third level degree and a post-graduate qualification in Quality Assurance would also be an advantage.  You will have a significant amount of experience in medical devices or other similarly regulated industry with a certified quality management system.

Who you are:

• Significant regulatory affairs experience including experience of international regulatory processes
• Knowledge of product certification testing requirements for active Medical Devices
• In depth knowledge of maintaining a certified Quality Management System
• Knowledge and application of Quality tools and Methodologies including lean six sigma, TQM etc.
• Experience of EN/MDD, ISO13485 and FDA requirements
• Trained QMS Internal Auditor
• Strong attention to detail
• Excellent Verbal and written communication skills
• Results orientated and a self-starter with the ability to work on own initiative
• Knowledge of and commitment to continuous improvement and problem solving
• Promote best practice and knowledge of the QSR and ISO/MDD standards
• Advanced Microsoft Office and reporting tool skills
• Strong project management skills