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- Tasks: Support the Quality Management System and ensure compliance with regulatory requirements.
- 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 kickstart their career 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.
Role Overview
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.
Key Responsibilities
- 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.
- Support internal and external audits, including document preparation and corrective actions.
- Work with cross-functional teams to implement CAPAs (Corrective and Preventive Actions) and track progress.
- 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.
Key Skills & Qualifications
- 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).
- Strong analytical and problem-solving skills with attention to detail.
- Excellent communication and teamwork abilities.
- Ability to manage multiple tasks and work in a fast-paced environment.
- Familiarity with document control systems and quality tools (e.g., FMEA, CAPA, Root Cause Analysis) is a plus.
Graduate QMS Engineer employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Graduate QMS Engineer
✨Tip Number 1
Familiarise yourself with ISO 13485 and FDA regulations. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality management in the medical device industry.
✨Tip Number 2
Network with professionals in the medical device field. Attend industry events or join relevant online forums to connect with people who can provide insights and potentially refer you to opportunities at companies like us.
✨Tip Number 3
Gain practical experience through internships or projects related to quality management systems. This hands-on experience will make you stand out as a candidate and show that you're ready to contribute from day one.
✨Tip Number 4
Prepare for behavioural interview questions by reflecting on your teamwork and problem-solving experiences. Being able to articulate how you've worked with others to achieve goals will be crucial in a collaborative role like this.
We think you need these skills to ace Graduate QMS Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant coursework, projects, and any internships related to Biomedical or Mechanical Engineering. Emphasise skills that align with the responsibilities of a QMS Engineer, such as analytical abilities and teamwork.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific experiences that demonstrate your understanding of quality management systems and regulatory compliance, and how they relate to the medical device industry.
Highlight Relevant Skills: Clearly outline your familiarity with ISO 13485, FDA regulations, and any quality tools you’ve used. If you have experience with document control systems or risk management activities, be sure to include those details.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role in quality management.
How to prepare for a job interview at Arevna
✨Know Your Regulations
Familiarise yourself with ISO 13485 and FDA 21 CFR Part 820. Being able to discuss these regulations confidently will show your understanding of the industry and your commitment to quality management.
✨Showcase Your Analytical Skills
Prepare examples from your studies or projects where you demonstrated strong analytical and problem-solving skills. This is crucial for a role that involves risk management and CAPA implementation.
✨Emphasise Teamwork
Highlight experiences where you worked in teams, especially in cross-functional settings. The ability to collaborate effectively is key in a role that requires working with various departments.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's QMS processes and their approach to regulatory compliance. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
