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- Tasks: Manage internal audits and support ISO 13485 Quality Management System.
- Company: Join a leading Medical Device Manufacturer making a difference in healthcare.
- Benefits: Gain valuable experience in a dynamic industry with opportunities for growth.
- Why this job: Be part of a team focused on quality and continuous improvement in medical devices.
- Qualifications: Experience in Quality Systems is essential; medical device background is a plus.
- Other info: Health & Safety awareness is crucial; training provided for team members.
The predicted salary is between 36000 - 60000 £ per year.
Our client, a leading Medical Device Manufacturer, is looking to appoint a Quality Management Systems (QMS) specialist who will be responsible for managing the internal audit program. Supporting the implementation and maintenance of the ISO 13485 certified Quality Management System across the company, including Quality Objectives, NC/CAPA management, and monitoring, measuring and reporting on QMS performance.
RESPONSIBILITIES OF THE ROLE:
- Manage the internal audit program, including scheduling audits and assigning auditors.
- Perform internal audits as assigned.
- Provide support during external audits, including collating pre-audit document requests.
- Manage the Quality Objectives procedure.
- Manage the NC/CAPA procedure.
- Provide backup/support for the document control and training activities on MasterControl.
- Provide training to other team members/colleagues as required.
- Any other duties as required.
- Continuous improvement - To initiate, support and lead Continuous Improvement projects as required.
- Health & Safety - All employees are to be aware and understand their health & safety responsibilities as laid out in the company Policy and its associated documentation.
QUALIFICATIONS AND EXPERIENCE:
- Experience of Quality Systems is essential.
- Experience within the Medical Devices industry is highly desirable.
- Excellent working knowledge of Microsoft Office (Word, Excel, OneDrive).
- Excellent written and oral communication skills in English.
Quality Management Systems / CAPA Specialist... employer: Jobbydoo
Contact Detail:
Jobbydoo Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Management Systems / CAPA Specialist...
✨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 and compliance during interviews.
✨Tip Number 2
Network with professionals in the medical device sector, especially those involved in quality management. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in QMS.
✨Tip Number 3
Prepare to discuss your experience with internal audits and CAPA management in detail. Be ready to share specific examples of how you've contributed to continuous improvement projects in previous roles, as this will highlight your practical knowledge and problem-solving skills.
✨Tip Number 4
Showcase your proficiency in Microsoft Office tools, particularly Excel, as data analysis is often a key part of managing QMS performance. Consider preparing a brief demonstration of how you've used these tools effectively in past positions to manage quality objectives or audit findings.
We think you need these skills to ace Quality Management Systems / CAPA Specialist...
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Management Systems and the Medical Devices industry. Use specific examples that demonstrate your skills in managing internal audits, NC/CAPA management, and continuous improvement projects.
Craft a Compelling Cover Letter: Write a cover letter that addresses the key responsibilities mentioned in the job description. Explain how your background aligns with their needs, particularly your experience with ISO 13485 and your ability to support external audits.
Showcase Your Communication Skills: Since excellent written and oral communication skills are essential, ensure your application is free from errors and clearly articulates your qualifications. Consider including examples of how you've effectively communicated in previous roles.
Highlight Continuous Improvement Initiatives: Mention any past experiences where you initiated or led continuous improvement projects. This will demonstrate your proactive approach and commitment to enhancing quality systems, which is crucial for this role.
How to prepare for a job interview at Jobbydoo
✨Showcase Your QMS Knowledge
Make sure to highlight your understanding of Quality Management Systems, especially ISO 13485. Be prepared to discuss how you've implemented or maintained such systems in previous roles.
✨Prepare for Audit Scenarios
Since the role involves managing internal audits, think of specific examples where you've conducted audits or supported external audits. Be ready to explain your approach and any challenges you faced.
✨Demonstrate Continuous Improvement Mindset
The company values continuous improvement, so come equipped with examples of projects you've led or contributed to that enhanced quality processes. Discuss the outcomes and what you learned from those experiences.
✨Communicate Clearly and Confidently
Given the importance of communication in this role, practice articulating your thoughts clearly. Use concise language and ensure you can explain complex concepts simply, especially when discussing NC/CAPA management.
