At a Glance
- Tasks: Manage ISO compliance, lead audits, and oversee sustainability initiatives.
- Company: Join Meditrade UK, a leader in quality management and environmental systems.
- Benefits: Enjoy 25 days holiday, private healthcare, and a cycle to work scheme.
- Why this job: Be part of a team that values quality, sustainability, and personal growth.
- Qualifications: Knowledge of ISO standards and EU regulations is essential.
- Other info: Opportunity for internal promotions and a supportive team environment.
The predicted salary is between 28000 - 46000 £ per year.
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:
35,000 – 40,000 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
Meditrade | Quality Specialist employer: Meditrade
Contact Detail:
Meditrade Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Meditrade | Quality Specialist
✨Tip Number 1
Familiarize yourself with ISO 9001 and ISO 14001 standards. Understanding these frameworks will not only help you in the interview but also demonstrate your commitment to quality management and environmental sustainability.
✨Tip Number 2
Research Meditrade UK’s current sustainability initiatives and be prepared to discuss how you can contribute to their goals, especially regarding GHG emissions and waste management. Showing genuine interest in their mission can set you apart.
✨Tip Number 3
Brush up on your knowledge of EU regulations related to medical devices, PPE, and cosmetics. Being able to speak confidently about these regulations will showcase your expertise and readiness for the role.
✨Tip Number 4
Prepare examples from your past experience where you successfully managed compliance or quality assurance processes. Real-life scenarios can illustrate your problem-solving skills and ability to handle challenges in a quality specialist role.
We think you need these skills to ace Meditrade | Quality Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality Specialist position at Meditrade. Understand the key responsibilities, such as managing ISO compliance and regulatory affairs, to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize any previous experience you have with ISO 9001, ISO 14001, or relevant regulatory frameworks like EU MDR. Use specific examples to demonstrate your expertise in quality management and compliance.
Showcase Technical Knowledge: Mention your familiarity with technical files and product specifications, especially regarding medical devices and personal protective equipment. This will show that you understand the technical aspects of the role.
Tailor Your Cover Letter: Craft a personalized cover letter that reflects your passion for quality assurance and sustainability initiatives. Discuss how your values align with Meditrade's commitment to compliance and environmental responsibility.
How to prepare for a job interview at Meditrade
✨Show Your Knowledge of ISO Standards
Make sure to brush up on your knowledge of ISO 9001 and ISO 14001. Be prepared to discuss how you have implemented or improved these systems in previous roles, as this will demonstrate your expertise and relevance to the position.
✨Understand Regulatory Requirements
Familiarize yourself with the EU MDR 2017/745 and other relevant regulations like PPE and cosmetic product regulations. Being able to discuss these regulations confidently will show that you are well-prepared for the role.
✨Prepare for Technical Questions
Expect questions related to technical evaluations and compliance with UKCA technical files. Think of examples from your past experience where you successfully managed product specifications or resolved product faults.
✨Demonstrate Team Collaboration Skills
Since the role involves supporting colleagues and ensuring effective communication, be ready to share examples of how you've worked collaboratively in a team setting to achieve quality and regulatory goals.