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- Tasks: Join our Quality Team to maintain and improve our ISO 13485 compliant Quality Management System.
- Company: Be part of a dynamic company making a difference in the medical device industry.
- Benefits: Enjoy competitive salary, performance bonuses, pension match, and private medical insurance.
- Why this job: Work on innovative technology that positively impacts millions while collaborating with diverse teams.
- Qualifications: 2+ years in a Quality role, knowledge of ISO 13485, and a relevant degree required.
- Other info: Ideal for detail-oriented problem solvers who thrive in fast-paced environments.
The predicted salary is between 36000 - 60000 £ per year.
We are expanding our team and are recruiting a Quality Systems Engineer. In this role you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for the maintenance of the quality system to ISO 13485 standards and associated product certification.
As a Quality Systems Engineer, you will:
Support the maintenance and continuous improvement of our ISO 13485 compliant Quality Management System with activities including document control, training management and change management.
Draft and update procedures, work instructions, and quality documentation.
Collaborate closely with Engineering (Software and Hardware) and Customer Support teams to investigate and identify root causes of quality-related issues from customer complaints, internal non-conformances and audit findings.
Assist with the implementation of CAPAs and closure of non-conformances.
Collaborate with cross-functional teams on documentation creation, risk management, and validation activities.
Support quality compliance for SaMD products, including lifecycle and version control.
Participate in internal and external audits.
Analyse quality data and contribute to process improvement initiatives.
Required experience:
2+ years of experience in a Quality role within the medical device industry
Hands-on knowledge of ISO 13485 and 21 CFR 820
Strong attention to detail and problem solving skills
Ability to work as part of a multi-disciplinary, fast-paced diverse team
Ability to work independently and prioritise tasks
Excellent communication, interpersonal, organisational and IT skills
Helpful experience:
Experience with electronic Quality Management Systems (eQMS)
Exposure to software as a medical device / IEC 62304
Technical/procedural writing experience
Familiarity with medical device regulatory requirements in the UK, EU, or US
Experience in an electronics-related medical device manufacturing environment would be advantageous
Minimum Qualifications:
A Bachelor’s or Master’s degree in a Life Science, Engineering, or a related field
Salary & Benefits:
Competitive salary and performance-based bonus scheme
Competitive benefits including pension match and private medical insurance
Work with an awesome team of smart and motivated people on cool and unique technology that can positively impact the lives of millions of people
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Quality Systems Engineer employer: HIRANI
Contact Detail:
HIRANI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Systems Engineer
✨Tip Number 1
Familiarise yourself with ISO 13485 standards and the specific requirements for quality management systems in the medical device industry. This knowledge will not only help you understand the role better but also demonstrate your commitment to quality compliance during interviews.
✨Tip Number 2
Network with professionals in the medical device sector, especially those who have experience in quality roles. Attend industry events or join relevant online forums to connect with others and gain insights that could give you an edge in your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality improvement initiatives in your previous roles. Highlighting your problem-solving skills and attention to detail will resonate well with the hiring team.
✨Tip Number 4
Research StudySmarter's products and services, particularly any related to software as a medical device (SaMD). Understanding our offerings will allow you to tailor your discussions and show how your background aligns with our mission and values.
We think you need these skills to ace Quality Systems Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality roles, particularly within the medical device industry. Emphasise your knowledge of ISO 13485 and any specific projects that demonstrate your problem-solving skills.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about quality systems and how your background aligns with the responsibilities of the Quality Systems Engineer role. Mention your experience with CAPAs and collaboration with cross-functional teams.
Showcase Relevant Skills: Highlight your attention to detail, organisational skills, and ability to work independently. Provide examples of how you've successfully managed tasks in a fast-paced environment, especially in relation to quality compliance and documentation.
Prepare for Potential Questions: Think about how you would respond to questions regarding your experience with audits, risk management, and quality data analysis. Be ready to discuss specific instances where you contributed to process improvements or resolved quality-related issues.
How to prepare for a job interview at HIRANI
✨Know Your ISO 13485 Inside Out
Make sure you have a solid understanding of ISO 13485 standards. Be prepared to discuss how you've applied these standards in your previous roles, and think of specific examples where you contributed to maintaining or improving quality systems.
✨Showcase Your Problem-Solving Skills
Prepare to share instances where you've identified root causes of quality-related issues. Highlight your analytical skills and how you've collaborated with teams to implement corrective actions and prevent future occurrences.
✨Demonstrate Team Collaboration
Since the role involves working closely with Engineering and Customer Support, be ready to discuss your experience in cross-functional teams. Share examples of successful collaborations and how they led to improved quality outcomes.
✨Be Ready for Technical Questions
Expect questions related to quality management systems and regulatory requirements. Brush up on your knowledge of eQMS and medical device regulations, and be prepared to explain how you've navigated these in your past roles.
