QA RA Officer

Job Title: Quality Assurance / Regulatory Affairs Officer

A leading global manufacturer, innovator and distributor that offers a complete portfolio of ophthalmic diagnostic & surgical equipment, including; slit lamps, biometers, perimeters, OCT devices, lasers, medical simulators, and microscopes. They also provide a comprehensive range of gold-standard micro-surgical instruments and procedures & implants.

Office Based in Essex with hybrid working remotely 2 days a week.

Salary: Up to £45k

Main Job Purpose: To support the Group Organisations to meet its quality / regulatory requirements.

Provides technical support, guidance and discipline for medical device manufacturing, engineering, and distribution, in the areas of Quality Assurance, regulatory compliance, and quality systems requirements. Use of root cause analysis to address problems and identify trends. Conducts Quality Audits across all organisations.

• Support in maintaining the documented quality systems across the Group.
• Support internal and external audits to demonstrate compliance with ISO 13485, UK MDR 2002, MDR 2017/745, MDD 93/42/EEC, MDSAP, plus other related external legislation as required, including interfacing with Regulatory Agencies where necessary.
• Support the preparation and maintenance of the necessary QMS and regulatory documentation.
• Supporting QA Admin team in product approvals to facilitate sales of medical devices in the UK and foreign markets.
• Evaluation of Suppliers and conduct approval audits as directed in accordance with organisational procedures.
• Carry out and document quality audits to ISO, UK, European and worldwide regulatory requirements.
• Support and facilitate quality improvements initiatives.
• Support and produce analysis data for trend identification for Management Reviews and non-conformances.
• Facilitate and carry out CAPA and non-conformance investigations to identify root cause in accordance with procedures.
• Review customer complaints for vigilance and maintain incident reporting in accordance with Regulatory Agency timescales.
• Ensure that Labour Standards Assurance Systems (LSAS) objectives and targets are met.

Experience in the Medical Device industry, working to BS EN ISO 13485 Quality Management system and Global Device Directive/Regulations.

Ensure Technical/Design History Files are effectively maintained and comply with country requirements including but not limited to UK MDR 2002, European (MDD/MDR) and 21 CFR part 820 requirements. E.g. maintenance of Essential Requirements, Risk Management and Post Market Surveillance.

Medical experience in a production / manufacturing environment.

Internal and external quality auditing experience to ISO 13485.

Has a passion for quality excellence.

Previous experience in a Quality Assurance role will be highly desirable including development of QMS documentation to ensure it evolves in accordance with regulatory and business requirements.

Knowledge of CAPA and non-conformance root cause tools.

Logical and practicable approach towards problem solving.

Quality Risk Management principles to ISO 14971.

Self-motivated but able to work as part of a team, including cross-functional teamwork.

Planning and facilitation skills with the ability to manage multiple projects simultaneously.

IT skills including knowledge of the ERP System e.g. Microsoft Dynamics AX 2012.

Attention to detail.

Coordination, logging and record maintenance.

Excellent communication skills with the ability to deal with people at all levels. With the ability to communicate effectively both verbally and in writing.

Must be able to manage stressful situations and to handle controversial issues; firmly adhering to the principles of the regulations and guidelines.

Ability to take on new skills and a positive approach to personal development, particularly developing a thorough knowledge of MDSAP requirements UK MDR 2002, European regulations, ISO 13485 guidelines, and other country specific requirements.

Knowledge regarding Biological evaluation, Clinical Evaluation reports and Post Market Surveillance in accordance with Technical file requirements.

Good understanding of GMP & GDPR requirements.

Knowledge of LSAS and awareness of high-risk countries and ethical trade issues within the supply chain.