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For Companies At a Glance
- Tasks: Support the Quality Management System and ensure compliance with medical device regulations.
- 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 quality and regulatory affairs.
- Qualifications: Bachelor’s degree in Biomedical or Mechanical Engineering, or related field required.
- Other info: Ideal for those passionate about improving healthcare through quality management.
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.
Locations
Graduate Quality Engineer employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Graduate Quality 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 our company.
✨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. Be ready to share specific examples that highlight your skills and how they relate to the responsibilities of a Graduate Quality Engineer.
We think you need these skills to ace Graduate 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 internships or academic projects.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific skills that align with the job description, such as your understanding of ISO standards or experience with CAPAs. Show how your background makes you a great fit for their team.
Highlight Relevant Skills: When filling out your application, ensure you highlight key skills mentioned in the job description, like analytical abilities and teamwork. Use examples from your studies or previous roles to demonstrate these skills effectively.
Proofread Your Application: Before submitting, take the time to proofread your application. 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 for a Quality Engineer role.
How to prepare for a job interview at Arevna
✨Know Your Regulations
Familiarise yourself with ISO 13485 and FDA 21 CFR Part 820. Understanding these regulations will show your commitment to quality management and demonstrate that you are serious about the role.
✨Showcase Your Analytical Skills
Prepare examples of how you've used analytical and problem-solving skills in your studies or previous experiences. This could be through projects, internships, or coursework related to quality management.
✨Emphasise Teamwork
Since the role involves working with cross-functional teams, be ready to discuss your experiences in team settings. Highlight any collaborative projects where you contributed to achieving a common goal.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's QMS and their approach to compliance and quality assurance. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
