Meditrade UK is looking for a Quality Specialist to join the team in our London office!
Role Objective: To maintain and improve the processes in relation to the ISO 9001 Quality Management System and ISO 14001 Environmental Management Systems, and update the Product's technical files whilst ensuring compliance with all related directives and regulations required to allow the business to operate in its chosen markets.
Salary: 32,500 - 37,500 GBP per annum OPERATIONS The responsibilities of this role are primarily the management of the day-to-day operational processes and documentation to ensure compliance and organisational effectiveness in this area.
You will lead internal and external audits to ensure process compliance and maintenance of the Company's ISO accreditations.
You will be responsible for the Company's Sustainability initiatives, keeping track of current company methods to monitor GHG emissions, waste management, and other relevant systems in order to report the Company's annual emissions to archive Net Zero.
You will need relevant knowledge regarding MDR, PPE, Cosmetics and Biocides regulations.
Regulatory and Product Accreditations Knowledge of EU MDR 2017/745 for Medical Devices (Class I, Is and IIa), and Regulation (EU) 2016/425 on personal protective equipment (PPE regulation).
Knowledge of EU Regulation No 1223/2009 on cosmetic products.
Help the Quality/RA Manager with the management of the company's global accreditation process ensuring that products are compliant to be sold in all dictated markets.
Management of existing accreditations and registrations to ensure continuity is held e.g.
MHRA registrations, OPSS registrations, etc.
Manage the application process for new accreditations required for new products and/or markets via an external third-party organisation Report on the Regulatory Affairs aspects and any need for improvements.
Quality Help the Dept.
in relationship to ISO 9001, ISO 14001, ISO 14064-1, and PPE extensions, including informing the relevant notified body of any significant changes to the quality system.
Help with the update of the Regulatory Affairs aspects to meet the requirements of the UK MDR 2002 (UKMDR).
Knowledge of compliance requirements regarding the labelling and artwork of the products depending on the product's category.
Register and ensure all relevant customer complaints are actioned as applicable and that the fault/recall system works when necessary.
Informing all competent authorities in the event of any serious product fault or recall.
Technical Maintain and ensure compliance with the UKCA technical files.
Maintenance of all product technical specifications to the organisation's required standard.
To act as a stakeholder and provide technical input to the New Product Development process ensuring that a compliant product is produced.
Take responsibility for all technical evaluations including answering all product queries and producing reports detailing product faults and likely root causes.
Liaise with the factories to resolve product faults and/or failures.
Monitoring/Reporting Report back to the Quality & Regulatory Affairs Manager on a periodic and/or ad-hoc basis.
Ensure that regular assessments of customer satisfaction are taken and that improvements are identified and implemented to ensure compliance with the Regulatory Affairs aspects.
Monitor the Company's GHG emissions and create annual sustainability reports.
Conduct Risk Analysis and Change Control, register Non-conformances when detected and create CAPAs.
PEOPLE (RELATIONSHIPS AND TEAM WORKING) To ensure that employees are supported effectively in relation to the Quality, Environmental and Regulatory Affairs aspects to allow them to deliver against set targets.
This includes support in terms of direction, product/process knowledge and backup in case of queries or issues.
To support an internal communication plan to raise internal knowledge of the quality management systems To provide support to colleagues on an individual or team basis as required.
What we offer: Pension 25 days holiday Private healthcare insurance Cycle to work scheme High degree of personal responsibility and decision-making freedom with internal promotion opportunities Regular company socials and team building