Senior QA/RA Specialist

Senior QA/RA Specialist


Our client a newly established Medical device company are currently seeking a Senior QA/RA Specialist to join their team. Reporting to the Head of Quality the QA/RA Specialist will assist Head of Quality in implementing new Quality Management Systems, establishing entity as a legal manufacturer and supporting the development of their new Product portfolio. The Senior QA/RA specialist will have strong knowledge of regulatory processes for EU and FDA product clearance and experience of quality in the context of R&D and design control



Role/Responsibilities:

• Responsible for the maintenance and development of The Quality management System
• Supporting the NPI programme from a quality Engineering and system aspect
• Supporting the Regulatory function
• Responsible for co-ordinating the NCR (Non-Conformance Report) and CAPA (Corrective and Preventive Action) process.
• Responsible for progressing CAPA’s to completion for Quality group and ensuring Quality CAPA’s are actioned in a timely manner
• Development and application of quality system as it relates to specified elements of the QMS, including training for compliance to ISO13485 and the FDA Quality System Regulations (QSR).
• Responsible for the development, implementation and ongoing maintenance of Quality Management Programs aimed at optimising product quality and processes in the sub-contract manufacturing operations & sub-tier suppliers, including supplier visits as required.
• Support the implementation and oversight of Supplier Quality Management Plans/Agreements with suppliers, including supplier review, supplier audits, issue resolution and scorecard-based supplier performance management
• Provide technical and quality support to transfer of products and associated technology from Design to sub-contract Electronic Manufacturers, including PQP development, new process qualification/validation and production start-up support / qualification.
• Create top level part numbers and develop BOM’s in line with internal QMS requirements (ISO 13485 and FDA) and ERP requirements.
• Responsible for Design Assurance (to ensure safety and efficacy) as it’s related to new product introductions and change management for legacy products as part of a Design team.
• Responsible for ensuring that the Risk Management File is developed throughout NPD process, according   ISO14971. Verify product specifications include outputs of risk management. Review test plans for verification/validation. Ensure verification and validation activities close and document all risk items. Liaise with test houses to arrange mandatory testing.
• Prepare regulatory submissions for required markets
• Maintain technical files for all products cleared
• Track and support product clearances and certifications to completion
• Keep up to date with new regulatory requirements across the different markets that company operate in.
• Manage product certification testing as required for new and existing products
• Provide RA support to internal and external customers
• Support internal and external audit processes as required
• Provide backup to other Quality Engineers as required by Department
• Perform other tasks as required by the Quality Systems Manager

• Educated to Degree levelin Engineering, Science or equivalent discipline
• 3+ years or moreMedical Devices or other similar regulated industry with a certified Quality Management System
• Knowledge and application of Quality tools and Methodologies
• High level of attention to detail
• Excellent Verbal and written communication skills
• Results orientated
• Trained QMS Auditor
• Knowledge of and commitment to Continuous Improvement and Problem Solving
• Self Starter- Ability to work with minimal supervision
• Promote best practice and knowledge of the QSR and ISO/MDD standards