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- Tasks: Lead the implementation of ISO 13485 and enhance quality management systems.
- Company: Join a growing Bristol-based medical device company focused on quality and innovation.
- Benefits: Enjoy a supportive team environment, potential for permanent role, and professional growth opportunities.
- Why this job: Make a real impact in quality assurance while working with a people-first leadership team.
- Qualifications: Experience in regulated manufacturing and knowledge of quality principles are essential.
- Other info: Quick interview process, with a focus on respect for your time.
The predicted salary is between 36000 - 60000 £ per year.
FTC – 18 month – Quality Specialist Role
Right now, a Bristol-based medical device company is ISO 9001 certified, but with manufacturing expanding, the focus is shifting to implementing ISO 13485 from the ground up. This is a standalone role, but you’re not alone. You’ll be the go-to QA Specialist onsite, partnering closely with a consultancy who’s already deeply embedded and supported by a wider global group. You’ll take the QMS from PDF-on-SharePoint to a living, breathing system. That means:
- Running a full gap assessment
- Adapting an existing 13485 QMS to fit this site
- Writing SOPs and work instructions that people actually understand
- Leading internal audits and driving certification forward
- Training and coaching the team
About You
You’ve probably worked in a regulated manufacturing setting before maybe ISO 13485, maybe ISO 9001 or even automotive, and you get why quality matters. But more than that, you know how to bring people with you. You’re proactive, self-motivated, and confident in your judgement. You’re not afraid to ask questions or suggest improvements. And you know how to talk about standards in a way that doesn’t put people to sleep. If you’ve done internal audits, written QMS documentation, and you know your way around quality principles, you’ll feel at home here.
Why This Role is Worth Your Time
You’ll be joining a company with serious growth: new facilities, new investment, and a people-first leadership team. You’ll own the QMS journey locally, but with support from a wider group of QA professionals. You’ll help build something that actually makes a difference and likely shape QMS approaches for other sites after this one. It’s an 18-month FTC to start, but they expect it to go permanent. Based in Bristol, working closely with the local leadership team. Interviews are one stage, onsite – quick and respectful of your time.
Quality Specialist employer: Medibeam
Contact Detail:
Medibeam Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist
✨Tip Number 1
Familiarise yourself with ISO 13485 standards and the specific requirements for medical device quality management systems. This will not only help you understand the role better but also allow you to speak confidently about how you can contribute to implementing these standards.
✨Tip Number 2
Prepare to discuss your experience in conducting internal audits and how you've successfully driven quality improvements in previous roles. Be ready to share specific examples that demonstrate your proactive approach and ability to engage others in the process.
✨Tip Number 3
Think about how you can make complex quality concepts accessible to non-experts. Prepare a few strategies or anecdotes that showcase your ability to communicate effectively and keep people engaged during training sessions.
✨Tip Number 4
Research the company’s recent growth and any new facilities or investments they’ve made. Being knowledgeable about their current situation will show your genuine interest in the role and help you align your skills with their future goals.
We think you need these skills to ace Quality Specialist
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the key responsibilities and requirements. Highlight your relevant experience in regulated manufacturing settings, particularly with ISO 13485 or ISO 9001.
Tailor Your CV: Customise your CV to reflect your experience with quality management systems, internal audits, and documentation writing. Use specific examples that demonstrate your proactive approach and ability to engage others in quality standards.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the importance of ISO standards. Mention how your skills align with the company's goals and your enthusiasm for contributing to their growth.
Proofread and Edit: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure clarity and professionalism in your writing, as this reflects your attention to detail, which is crucial for a Quality Specialist.
How to prepare for a job interview at Medibeam
✨Understand ISO Standards
Make sure you have a solid grasp of ISO 9001 and ISO 13485 standards. Be prepared to discuss how your previous experience aligns with these standards and how you can implement them effectively in the new role.
✨Showcase Your Communication Skills
Since you'll need to write SOPs and train the team, demonstrate your ability to communicate complex quality concepts clearly. Bring examples of how you've successfully engaged teams in the past.
✨Prepare for Practical Scenarios
Think about real-life situations where you've conducted internal audits or adapted QMS documentation. Be ready to share specific examples that highlight your problem-solving skills and proactive approach.
✨Express Your Passion for Quality
Convey your enthusiasm for quality assurance and how it impacts the overall success of a company. Share why you believe quality matters and how you can inspire others to embrace this mindset.
