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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 responsibilities are key; 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. All employees have a legal duty to take all care needed for the safety of themselves and others who may be affected by their activities and to co-operate with the employer in complying with statutory requirements.
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: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences 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 allow you to speak confidently about how you can contribute to maintaining compliance.
✨Tip Number 2
Network with professionals in the medical device sector, especially those who have experience in quality management. Attend relevant industry events or join online forums to gain insights and potentially get referrals that could strengthen your application.
✨Tip Number 3
Prepare to discuss your experience with internal audits and CAPA management during interviews. Be ready to provide examples of how you've successfully managed these processes in previous roles, as this will demonstrate your capability to handle the responsibilities outlined in the job description.
✨Tip Number 4
Showcase your proficiency in Microsoft Office tools, particularly Excel, as data analysis and reporting are crucial in quality management. Consider preparing a brief demonstration of how you've used these tools effectively in past positions to enhance your candidacy.
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 and compliance with ISO 13485.
Craft a Compelling Cover Letter: Write a cover letter that addresses the key responsibilities of the role. Mention your experience with NC/CAPA management and any continuous improvement projects you've led. Show enthusiasm for the position and the company.
Highlight Relevant Skills: In your application, emphasise your proficiency in Microsoft Office and your excellent communication skills. Provide examples of how these skills have contributed to your success in previous roles.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in quality management.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Quality Management Systems
Make sure you have a solid understanding of Quality Management Systems, especially ISO 13485. Be prepared to discuss your experience with internal audits and how you've contributed to maintaining or improving quality standards in previous roles.
✨Showcase Your Medical Device Experience
If you have experience in the medical devices industry, highlight it! Discuss specific projects or challenges you've faced and how you overcame them. This will demonstrate your relevance to the role and your ability to adapt to their environment.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to handle non-conformities and CAPA management. Think of examples from your past work where you successfully managed similar situations and be ready to explain your thought process.
✨Communicate Clearly and Confidently
Since excellent communication skills are essential for this role, practice articulating your thoughts clearly. Use concise language and ensure you can explain complex concepts simply, as you may need to train others or present findings during audits.
