QA/RA Officer

3 weeks ago

Harlow Essex, United Kingdom Progress Sales Recruitment Full time €45,000

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. Performance Measures

  • 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.
Core Competencies 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. Flexibility. 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. Job Role Support the preparation and submission of technical documentation required for regulatory market registration submissions by the QA/RA team, including risk, post-market documentation and reports. Supports all the organisations to achieve root cause identification and solution resolution. Plan, carry out and document Quality audits. Maintain and co-ordinate risk assessments, Clinical review updates in line with Engineering change requests. Support quality awareness and improvement activities within all areas of the Company. Create data summaries for analysis and trend identification. Support purchasing with supplier investigations including LSAS compliance. Evaluation of Suppliers and conduct approval audits Support and liaise with internal departments regarding required corrective and preventative actions. Carries out evaluation of effectiveness of corrective measures. Conducts and supports complaints investigations Liaise directly with other departments on any other matters relating to the effective running of the department and the business as a whole. Provide information, as requested for both internal and external auditors. Reporting all Vigilance incidents, which could affect quality to the Regulatory Affairs/ Quality Assurance Manager in a timely fashion. Supports the Quality department regarding ERP maintenance of quality modules. Provide support and guidance on quality and regulatory affairs to other companies within the Group. Ensure suppliers are set up on the system and that they complete all the relevant documentation including LSAS before they are classed as approved and highlight any risks and concerns in the supply chain to the Quality Assurance and Regulatory Manager and Management Representative, including any potential country specific risks

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