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- Tasks: Lead the creation of a Quality Management System for a growing orthopaedic company.
- Company: Join a cutting-edge firm specialising in osteosynthesis solutions for orthopaedics.
- Benefits: Enjoy a mix of remote work and office flexibility, plus opportunities for professional growth.
- Why this job: Be part of a dynamic team making a real impact in the medical devices industry.
- Qualifications: Experience with ISO 13485, auditing, and strong communication skills are essential.
- Other info: Ideal for self-motivated individuals eager to shape quality standards in healthcare.
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.
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Quality Manager - Orthopaedics employer: Guided Solutions
Contact Detail:
Guided Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Manager - Orthopaedics
✨Tip Number 1
Network with professionals in the medical devices industry, especially those who have experience with ISO 13485 and quality management systems. Attend relevant conferences or webinars to make connections and learn more about the latest trends in orthopaedics.
✨Tip Number 2
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as UKRP, HTA, and GDPR. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 3
Prepare to discuss your previous experiences in managing a Quality Management System. Be ready to share specific examples of how you've implemented ISO standards and handled audits, as this will showcase your expertise.
✨Tip Number 4
Research the company’s products and their impact on the orthopaedic sector. Understanding their offerings will allow you to tailor your conversation during interviews and show that you're genuinely interested in contributing to their mission.
We think you need these skills to ace Quality Manager - Orthopaedics
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in the Medical Devices Industry, particularly with ISO 13485 and 9001. Emphasise any previous roles as a Quality Manager and your familiarity with regulatory requirements like MDR and UKCA certification.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities mentioned in the job description. Discuss your experience in creating Quality Management Systems and managing audits, and express your enthusiasm for contributing to a company focused on osteosynthesis solutions.
Showcase Relevant Skills: In your application, clearly outline your problem-solving skills and communication abilities. Provide examples of how you've successfully managed a QMS and liaised with manufacturers or contractors to ensure compliance.
Be Clear About Availability and Salary Expectations: When submitting your application, include your availability for starting the role and your salary expectations. This shows that you are serious about the position and helps the employer gauge your fit for the role.
How to prepare for a job interview at Guided Solutions
✨Know Your Standards
Familiarise yourself with ISO 13485 and ISO 9001 standards, as well as the specifics of MDR and UKCA certification. Be prepared to discuss how your previous experience aligns with these standards and how you can implement them in the new role.
✨Showcase Your Auditing Experience
Highlight your previous experience with the auditing process. Be ready to provide examples of audits you've conducted or participated in, and explain how you ensured compliance and improved quality management systems.
✨Demonstrate Problem-Solving Skills
Prepare to discuss specific challenges you've faced in quality management and how you resolved them. This will showcase your problem-solving abilities and your proactive approach to maintaining quality standards.
✨Communicate Effectively
Since excellent communication skills are crucial for this role, practice articulating your thoughts clearly and concisely. Be ready to discuss how you liaised with various stakeholders, including overseas manufacturers, to ensure compliance and quality.
