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For Companies At a Glance
- Tasks: Support the Quality Management System and ensure compliance with regulatory standards.
- Company: Join a leading medical device company focused on innovation and patient safety.
- Benefits: Gain hands-on experience in a dynamic environment with opportunities for growth.
- Why this job: Perfect for recent graduates eager to make an impact in medical device quality.
- Qualifications: Bachelor’s degree in Biomedical or Mechanical Engineering, or related field required.
- Other info: Ideal for those passionate about quality management and regulatory affairs.
The predicted salary is between 28800 - 48000 £ per year.
About the Company
Our client is a leading medical device company dedicated to innovation, quality, and patient safety. We specialize in developing cutting-edge medical technologies and are committed to maintaining the highest regulatory and quality standards.
We are seeking a Graduate QMS Engineer to support our Quality Management System (QMS) and ensure compliance with regulatory requirements. This role is ideal for a recent graduate with a background in Biomedical Engineering, Mechanical Engineering, or a related discipline who is eager to develop their career in medical device quality and regulatory affairs.
- Assist in the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations.
- Help manage document control, including the review, approval, and distribution of quality records.
- Assist in risk management activities, ensuring compliance with ISO 14971.
- Support training initiatives on QMS processes for employees.
- Participate in supplier quality assessments and performance monitoring.
- Ensure compliance with regulatory requirements and support regulatory submissions as needed.
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Management, or a related field.
Understanding of ISO 13485, FDA 21 CFR Part 820, and medical device regulations (preferred but not essential).
Familiarity with document control systems and quality tools (e.g., FMEA, CAPA, Root Cause Analysis) is a plus.
Locations
Graduate Engineer / Quality Engineer employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Graduate Engineer / Quality Engineer
✨Tip Number 1
Network with professionals in the medical device industry. Attend relevant conferences, workshops, or webinars to meet people who work in quality management and regulatory affairs. This can help you gain insights into the field and potentially lead to job referrals.
✨Tip Number 2
Familiarise yourself with ISO 13485 and FDA regulations. Even if you don't have direct experience, showing that you understand these standards can set you apart. Consider taking online courses or certifications to boost your knowledge.
✨Tip Number 3
Engage with our company on social media platforms. Follow us on LinkedIn and interact with our posts. This not only shows your interest in our company but also helps you stay updated on any news or job openings.
✨Tip Number 4
Prepare for potential interviews by practising common questions related to quality management systems and regulatory compliance. Think about how your academic projects or internships relate to the role, and be ready to discuss them.
We think you need these skills to ace Graduate Engineer / Quality Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant coursework and projects related to Biomedical or Mechanical Engineering. Emphasise any experience with quality management systems or regulatory compliance, even if it's from academic projects.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific aspects of the job description that excite you, such as supporting QMS processes or participating in supplier quality assessments.
Highlight Relevant Skills: Clearly outline any skills that align with the job requirements, such as familiarity with ISO standards, document control systems, or quality tools like FMEA and CAPA. Use examples to demonstrate how you've applied these skills in your studies or internships.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in quality engineering.
How to prepare for a job interview at Arevna
✨Show Your Passion for Quality
Make sure to express your enthusiasm for quality management and regulatory affairs. Talk about any relevant projects or coursework that sparked your interest in maintaining high standards in medical devices.
✨Familiarise Yourself with Key Regulations
Before the interview, brush up on ISO 13485 and FDA 21 CFR Part 820. Being able to discuss these regulations confidently will demonstrate your commitment to understanding the industry standards.
✨Prepare Examples of Problem-Solving
Think of specific instances where you applied quality tools like FMEA or Root Cause Analysis during your studies or internships. Sharing these examples will showcase your practical knowledge and analytical skills.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's QMS and their approach to continuous improvement. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
