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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: Enjoy opportunities for continuous improvement and professional development.
- Why this job: Be part of a team that values quality and safety in medical devices.
- Qualifications: Experience in Quality Systems and Medical Devices is essential.
- Other info: Training provided; health and safety responsibilities are key.
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 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 events or join relevant online forums 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 successfully managed audits or improved quality processes in previous roles, as this will showcase your practical expertise.
✨Tip Number 4
Research the company’s current quality initiatives and any recent news related to their products or services. This will allow you to tailor your conversation during interviews and show that you are genuinely interested in contributing to their quality objectives.
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 CAPA processes.
Craft a Strong 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 continuous improvement projects.
Highlight Relevant Skills: In your application, emphasise your proficiency in Microsoft Office and your communication skills. Mention any training or mentoring experience you have, as this is important for the role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter to eliminate any errors. A polished application reflects your attention to detail, which is crucial in quality management roles.
How to prepare for a job interview at Cpl Life Sciences
✨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 managing the internal audit program is a key responsibility, think of examples from your past experiences where you successfully conducted audits or supported external audits. This will demonstrate your practical knowledge.
✨Emphasise Continuous Improvement
Be ready to talk about any Continuous Improvement projects you've led or participated in. Companies value candidates who can contribute to enhancing processes and systems.
✨Communicate Clearly
Given the importance of communication in this role, practice articulating your thoughts clearly. Prepare to explain complex concepts simply, as you may need to train colleagues on QMS procedures.
