QA Associate

Assist in the maintenance of the IDS Boldon Quality Management System; and to ensure that manufactured product (IVD) is manufactured and distributed in accordance with the appropriate International Standards & Regulations.

• Assist in the maintenance of the IDS Boldon Quality Management System in accordance with appropriate International Standards & Regulations and Group Standards for the manufacture of IVD products at IDS Boldon.
• Complete reviews of batch manufacturing records to ensure adherence to requirements leading to the QA Release of intermediate and final product at IDS Boldon.
• Interface with R&D and Operations departments to ensure the efficient and compliant transfer of new products from R&D to IDS Boldon Production.
• Ensure that products and processes comply with the relevant requirements of the quality management system.
• Evaluate and continually improve Quality Systems to ensure that products and processes meet defined quality standards and comply with the appropriate international standards and regulations.
• Facilitation of non-conformance investigation, root cause analysis and implementation of effective CAPA for process related concerns.
• Assessment and approval of changes to ensure quality impact analysis, risk management and validation activities are identified and carried out.
• Conduct internal quality audits and assist with external audits
• Assist in the investigation and analysis of failure, corrective and preventive action to respond to customer complaints. Including assessment of potential reportable events.
• Creation, maintenance and approval of all QMS documentation
• Completion and analysis of QA Metrics towards Quality Management Reviews
• QMS document control, including archiving & periodic reviews
• Ensuring the promotion of quality awareness throughout the Company
• Deliver training to build quality awareness
• Release of quarantined materials
• Review, approval and administration of Product Notifications
• Preparation of Post Market Surveillance Reports
• Administration of on-line training system
• Monitor the progress of quality activities on a daily/weekly basis ensuring that there is continuous drive/focus on meeting target dates and KPIs
• Assist with the preparation, execution and completion of validation documentation ensuring compliance to all relevant Quality Standards and Regulatory requirements.
• Compilation of Euratom returns as required

Qualifications

• GCSE level or higher qualifications (OR at least 2-3 years relevant experience)

Skills & Knowledge

• Knowledge of, and experience in the application of, ISO 13485 and other quality management system requirements required under MDSAP
• Good attention to detail; and communication skills both internal and external
• Ability to work as part of a team, departmentally and inter-departmentally
• Ability to work under pressure and to strict deadlines
• Ability to work in an autonomous, self-managed role.
• Good organization and influencing skills

Experience

• Experience of applicable regulations for manufacture and distribution of devices in globally
• Knowledge of Quality Systems and their operation would be a benefit
• Very good experience working as an administrator in the manufacturing industry