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- Tasks: Create and manage a Quality Management System for innovative orthopaedic solutions.
- Company: Leading provider of cutting-edge osteosynthesis solutions in the medical devices sector.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Why this job: Join a dynamic team making a real difference in orthopaedics and patient care.
- Qualifications: Experience with ISO 13485, quality management, and excellent communication skills.
- Other info: Exciting role with a mix of remote and office-based work, plus career advancement potential.
The predicted salary is between 36000 - 60000 £ per year.
Our client's expertise lies in delivering cutting-edge osteosynthesis solutions to the orthopaedic sector, with a strong focus on extremities and fragility fractures across the skeletal system. Due to their continued growth, they are looking for a Quality Manager with experience in the Medical Devices Industry. Their main duty will be to create the Quality Management System (ISO 13485) as well as help with other quality / regulatory requirements – UKRP, HTA, MSAT, Carbon Reduction plans, GDPR etc. The role will be a mixture of remote working as well as office-based when needed.
Key responsibilities:
- Creating a QMS for a newly established company according to ISO 13485 / 9001.
- Keeping UKRP Register up to date.
- Helping to write new policies GDPR / MSAT.
- Managing the Quality Management system day to day, doing internal audits, liaising with notified bodies etc.
- Checking technical files.
- Liaising with overseas manufacturers / contractors to ensure compliance.
- Carry out and assist with audits throughout the business.
- Ensure procedures are in place and associated documentation is correct.
- Oversee the implementation of an electronic document management system.
To be considered for the role, you must closely match the following criteria:
- Knowledge of ISO13485 & 9001 within Medical Devices.
- Knowledge of MDR and UKCA certification (technical files).
- Previous experience as a Quality Manager.
- Have previous experience of the auditing process.
- Capable of fully managing a QMS.
- Have excellent communication skills both verbal and written.
- Be self‑motivated and have a positive attitude.
- Good problem‑solving skills.
If you are interested in this position, please provide an up‑to‑date CV as soon as possible, along with your availability and your salary expectation.
Quality Manager - Orthopaedics in England employer: Guided Solutions
Contact Detail:
Guided Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Manager - Orthopaedics in England
✨Tip Number 1
Network like a pro! Reach out to people in the orthopaedics and medical devices industry. Attend events, join online forums, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and 9001. Be ready to discuss how you've implemented quality management systems in the past. Show them you're not just familiar with the standards but can also apply them effectively.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email. It shows your enthusiasm for the role and keeps you fresh in their minds. Plus, it’s a great chance to reiterate why you’re the perfect fit.
✨Tip Number 4
Apply through our website! We’ve got loads of resources to help you ace your application. Plus, applying directly gives you a better chance of being noticed by hiring managers. So, don’t wait – get your CV in there!
We think you need these skills to ace Quality Manager - Orthopaedics in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience with ISO 13485 and 9001, as well as any relevant auditing experience. We want to see how your skills match the role, so don’t be shy about showcasing your achievements in the Medical Devices Industry!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Quality Manager role. Mention your knowledge of regulatory requirements like UKRP and GDPR, and how you can contribute to our mission in the orthopaedic sector.
Be Clear and Concise: When filling out your application, keep your language clear and to the point. We appreciate straightforward communication, so avoid jargon unless it’s necessary. This will help us understand your qualifications better!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it makes the whole process smoother for everyone involved.
How to prepare for a job interview at Guided Solutions
✨Know Your Standards
Make sure you’re well-versed in ISO 13485 and 9001. Brush up on the specifics of these standards and be ready to discuss how you've applied them in your previous roles. This will show that you’re not just familiar with the terms, but you can also implement them effectively.
✨Showcase Your Auditing Experience
Prepare examples from your past where you’ve successfully managed audits or compliance checks. Be ready to explain your approach to internal audits and how you liaised with notified bodies. This will demonstrate your hands-on experience and problem-solving skills.
✨Communicate Clearly
Since excellent communication is key for this role, practice articulating your thoughts clearly and concisely. You might want to prepare a few scenarios where you had to communicate complex information to different stakeholders, showcasing your verbal and written skills.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to quality management. Think about how you would handle issues like non-compliance or implementing new policies. This will help you demonstrate your critical thinking and proactive attitude.
