At a Glance
- Tasks: Join a dynamic team to manage quality processes in medical device innovation.
- Company: Be part of a growing Biomedical Devices company based in Twickenham.
- Benefits: Enjoy a competitive salary, benefits, and a 4-day working week.
- Why this job: Make a real impact by bringing new technology to global markets.
- Qualifications: Degree in Biomedical or Engineering, with 3 years in a quality role.
- Other info: Fluency in English and strong IT skills are essential.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Quality Engineer – £competitve salary + benefits – 4 day working week – Twickenham based
We have an exciting new role for a Quality Engineer to form part of this innovative and growing Biomedical Devices company. You will be joining an experienced team with the vision to grow the business worldwide. You will have the opportuninty to have a real impact by bringing new technology to new regions.
Main responsibilities will include the following:
- Quality Management – managing technical documentation, CAPA and writing/maintaining processes and procedures in compliance with ISO13485 QMS system. Verification and validation of ISO process and procedures.
- Management of the Technical Files.
- Risk Management File – maintenance and update of RMF in accordance with ISO14971.
- Active role in 3 new design projects including management of technical documentation in design process.
- Conduct internal audits and support external audits.
- Support on FDA registration for new products. Registration of products in different regions.
- Support the implementation and maintenance of the Post-Market Surveillance (PMS) system
- Collaborate with Purchasing to maintain a controlled list of approved critical suppliers, including risk classification.
Essential skills for the role:
- Degree in a Biomedical or Engineering-based discipline
- IT skills MS Office
- Must be fluent in written and spoken English to C1 level
Knowledge & Experience, Essential:
- Good understanding of reporting requirements under MDR/ISO-13485
- Minimum 3 years working in a quality role at a medical device company.
If you are looking for your next step within Engineering for a growing innovative company based in Twickenham please send your CV to the details provided. It is essential you meet the requirements to be shortlisted for the role. Salary dependent on experience.
Please be advised CVs will be treated in the strictest of confidence and that your application will not be forwarded without your permission. We aim to respond promptly to your application however, due to the high level of CVs we receive we are only able to respond to applicants whose profile matches our Clients requirements.
Quality Engineer - Medical Devices employer: Euro London
Contact Detail:
Euro London Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer - Medical Devices
✨Tip Number 1
Familiarise yourself with ISO standards, particularly ISO13485 and ISO14971. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality management in the medical device sector.
✨Tip Number 2
Network with professionals in the biomedical field, especially those who have experience in quality roles. Attend industry events or join relevant online forums to gain insights and potentially get referrals that could lead to job opportunities.
✨Tip Number 3
Prepare to discuss specific examples of your experience with CAPA processes and internal audits. Being able to articulate your hands-on experience will set you apart from other candidates and show your practical knowledge.
✨Tip Number 4
Research the company’s recent projects and innovations in the biomedical devices space. Showing that you are informed about their work and how you can contribute will make a strong impression during the interview process.
We think you need these skills to ace Quality Engineer - Medical Devices
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality management, particularly in the medical devices sector. Emphasise your familiarity with ISO13485 and ISO14971, as well as any relevant projects you've worked on.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the responsibilities mentioned in the job description. Discuss your experience with CAPA, technical documentation, and internal audits to demonstrate your suitability for the role.
Highlight Relevant Skills: In your application, clearly outline your IT skills, especially your proficiency with MS Office. Mention your fluency in English and any other languages, as this is essential for the role.
Showcase Your Impact: Provide examples of how you have contributed to previous projects or roles, particularly in terms of risk management and compliance with regulatory standards. This will help illustrate your potential impact at the new company.
How to prepare for a job interview at Euro London
✨Know Your Standards
Familiarise yourself with ISO 13485 and ISO 14971 standards. Be prepared to discuss how you have applied these in your previous roles, especially in managing technical documentation and risk management.
✨Showcase Your Experience
Highlight your experience in quality roles within the medical device industry. Be ready to provide specific examples of CAPA processes you've managed or internal audits you've conducted.
✨Demonstrate Technical Knowledge
Be prepared to discuss the verification and validation processes you’ve implemented. Understanding the FDA registration process and post-market surveillance will also be beneficial.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current projects and their approach to quality management. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.