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- Tasks: Lead the Quality Management System and ensure compliance in a dynamic medical device environment.
- Company: Innovative medical device company focused on quality and continuous improvement.
- Benefits: Key role in a growing organisation with opportunities for professional development.
- Why this job: Make a real impact on healthcare by driving quality and regulatory excellence.
- Qualifications: Experience in Quality Management and strong knowledge of relevant regulations required.
- Other info: Join a passionate team with a 4.9-star service rating on Google.
The predicted salary is between 50000 - 65000 £ per year.
MCS Group is delighted to be partnering with our successful client, who is an innovative medical device company. They are seeking an experienced Quality Manager to take ownership of the Quality Management System (QMS). This role will be key to ensuring compliance across clinical, development, and commercial operations while driving a strong culture of quality, continuous improvement, and regulatory excellence.
Responsibilities
- Lead and maintain the Quality Management System (QMS) in line with ISO 13485, MDR, and FDA regulations, ensuring ongoing compliance and continuous improvement.
- Oversee key quality processes, including CAPA, audits, risk management, complaints, and post‑market surveillance.
- Support clinical and regulatory activities, including submissions, vigilance reporting, and compliance with ISO 14155 and GCP.
- Drive cross‑functional quality initiatives, training, and performance monitoring to embed a strong culture of compliance and operational excellence.
Qualifications
- Experience in Quality Management within medical devices or life sciences.
- Strong knowledge of ISO 13485, MDR, FDA 21 CFR Part 820, and related frameworks.
- Experience with CAPA, audits, risk management, and post‑market surveillance.
- Knowledge of clinical and regulatory requirements (ISO 14155, GCP).
- A degree in Life Sciences, Engineering, or related field (additional certifications desirable).
- Experience with eQMS systems.
Benefits
- A key role within a growing and innovative organisation.
To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Kathy Donaghey Technical and Engineering Manager at MCS Group 028 96935521. Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs www.mcsgroup.jobs.
Quality Manager (Medical Device) in Belfast employer: MCS Group | Your Specialist Recruitment Consultancy
Contact Detail:
MCS Group | Your Specialist Recruitment Consultancy Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Manager (Medical Device) in Belfast
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Quality Manager role. You never know who might have the inside scoop on an opportunity that’s not even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485, MDR, and FDA regulations. Be ready to discuss how you've implemented quality management systems in the past and share specific examples of your success in driving compliance and continuous improvement.
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications with a friendly email or call to express your enthusiasm for the role. This shows initiative and can help you stand out from the crowd.
✨Tip Number 4
Check out our website for the latest job openings. We’re always updating our listings, and applying directly through us can give you a better chance of landing that Quality Manager position. Plus, we’re here to support you every step of the way!
We think you need these skills to ace Quality Manager (Medical Device) in Belfast
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Manager role. Highlight your experience with ISO 13485, CAPA, and any relevant regulatory frameworks. We want to see how your background aligns with what we're looking for!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've driven quality improvements or compliance in previous roles. This helps us see the impact you've made in your past positions.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management in medical devices and how you can contribute to our innovative team. Keep it concise but engaging!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at MCS Group | Your Specialist Recruitment Consultancy
✨Know Your Standards
Make sure you’re well-versed in ISO 13485, MDR, and FDA regulations. Brush up on how these standards apply to the role of a Quality Manager in medical devices. Being able to discuss specific examples of compliance and continuous improvement will show your expertise.
✨Showcase Your Experience
Prepare to talk about your previous experience with CAPA, audits, and risk management. Have concrete examples ready that demonstrate your ability to lead quality processes and drive initiatives. This will help you stand out as a candidate who can take ownership of the QMS.
✨Understand the Company Culture
Research the company’s values and culture, especially their approach to quality and innovation. Be ready to discuss how you can contribute to fostering a strong culture of compliance and operational excellence within their team.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s current quality initiatives and challenges they face. This not only shows your interest but also gives you a chance to demonstrate your knowledge of the industry and how you can add value.