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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. 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 Title: Quality Assurance - Servicing Oversight Lead Location: Hybrid (Home based 3 days, 2 days in the London, Victoria office) Salary: Up to £45,000 Hours: Monday to Friday 9 am to 5 pm Benefits: Generous holiday entitlement Flexibility to work from home up to 3 days per week Generous pension scheme Health insurance Enhanced maternity/paternity leave Life Insurance Cycle-to-work scheme Regular Social events About our client and the position of Quality Assurance - Servicing Oversight Lead Reporting to the Risk and Compliance Director the Quality Assurance - Servicing Oversight Lead is a critical role in ensuring that customers have a positive experience. You will be responsible for the efficient and effective oversight of all servicing activity. You will be actively involved in assurance activity and take responsibility for making any improvements to the servicing system and processes. Responsibilities for the role of Quality Assurance - Servicing Oversight Lead Manage and oversee third-party Quality Assurance processes for our servicing operations, as part of ongoing due diligence and as part of Business-as-Usual oversight. Act as the subject matter expert for Quality Assurance processes within the servicing lifecycle. Fostering a culture of continuous improvement through the feedback being given. Take a leadership role when identifying findings and enhancements which contribute to an environment of continuous improvement, making recommendations and overseeing these to completion. Create and assist with delivering training on areas for improvement, taking ownership for implementation where required alongside the Head of Operations/Risk & Compliance Director. Provide feedback to the servicing team on training needs. Challenge processes and highlight areas for improvement. Take ownership of key thematic review areas, conducting fieldwork, reporting and managing the timely completion of findings. Submission of and contribution to reporting (with colleagues) to the Risk Committee. Assist the Head of Audit Oversight and Head of Operations with audit activity, as required. Experience required for the role of Quality Assurance - Servicing Oversight Lead Proven experience in handling audit or Quality Assurance activities gain in a mortgage lending or mortgage servicing business. Strong analytical and problem-solving skills, with the ability to make evidence-based and reasonable decisions. Ability to make evidence-based, accountable decisions. Excellent written and verbal communication skills, including formal report writing ability. Significant experience in a Quality Assurance or mortgage underwriting role. Previous experience in collating, analysing and presenting data which provides senior management with meaningful insights into the outputs of monitoring activity. Proven track record of taking a proactive, common-sense approach to challenges in previous roles. Ability to provide clear and timely feedback collaboratively. Ability to assist senior management with identifying areas for improvement highlighting key strengths throughout the function and liaising with other business areas to ensure consistency. Ability to manage own workload within deadlines and to identify areas of continuous improvement, taking ownership of these key workstreams to delivery. Flexible approach to Quality Assurance preparation. Strong audit oversight experience and an ability to provide support, answer queries and proactively engage with audit counterparts. For more information regarding the role of Quality Assurance - Servicing Oversight Lead please get in touch with us. Stellar Select is acting as an employment agency and is a corporate member of the REC. Due to a high volume of applications, we will only contact you if your application has been successful. We aim to contact all successful contacts within two business days.