At a Glance
- Tasks: Manage internal audits and support ISO 13485 QMS implementation.
- Company: Join a leading Medical Device Manufacturer making a difference in healthcare.
- Benefits: Enjoy full-time employment with opportunities for continuous improvement and professional growth.
- Why this job: Be part of a team that values quality and safety in medical devices.
- Qualifications: Experience in Quality Systems and the Medical Devices industry is essential.
- Other info: Mid-senior level role with a focus on engineering and quality assurance.
The predicted salary is between 36000 - 60000 £ per year.
Our client, a leading Medical Device Manufacturer, is seeking a Quality Management Systems (QMS) specialist responsible for managing the internal audit program and supporting the implementation and maintenance of the ISO 13485 certified QMS across the company.
Key responsibilities include:
- Managing and performing internal audits.
- Overseeing Quality Objectives and NC/CAPA procedures.
- Supporting document control and training activities, including MasterControl.
- Providing training to team members as needed.
- Leading or supporting continuous improvement initiatives.
- Ensuring health & safety responsibilities are understood and adhered to.
Qualifications and Experience:
- Experience with Quality Systems is essential.
- Experience in the Medical Devices industry is highly desirable.
- Proficiency in Microsoft Office Suite.
- Excellent communication skills in English.
Additional Details:
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Engineering and Quality Assurance
- Industry: Medical Equipment Manufacturing
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 who have experience with QMS and CAPA processes. Attend industry conferences or webinars to make connections and gain insights that could give you an edge in your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed internal audits or led continuous improvement projects in previous roles. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your proficiency in Microsoft Office Suite by being ready to discuss how you've used these tools to support document control and training activities. Highlighting your technical skills can reinforce your suitability for the role.
We think you need these skills to ace Quality Management Systems / CAPA Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Quality Management Systems / CAPA Specialist. Familiarise yourself with ISO 13485 and the specific requirements of the medical device industry.
Tailor Your CV: Highlight your relevant experience in quality systems and the medical devices sector. Use specific examples to demonstrate your proficiency in managing internal audits, NC/CAPA procedures, and continuous improvement projects.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality management and your understanding of the role. Mention how your skills align with the company's needs and express your enthusiasm for contributing to their QMS.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail.
How to prepare for a job interview at Cpl Life Sciences
✨Showcase Your QMS Knowledge
Make sure to brush up on your knowledge of Quality Management Systems, especially ISO 13485. Be prepared to discuss how you've implemented or maintained these systems in previous roles, as this will demonstrate your expertise and relevance to the position.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to describe how you would handle specific situations related to NC/CAPA procedures or internal audits. Think of examples from your past experience where you successfully managed similar challenges, as this will highlight your problem-solving skills.
✨Emphasise Continuous Improvement
Since leading continuous improvement projects is a key responsibility, be ready to discuss any initiatives you've led or contributed to. Highlight the outcomes of these projects and how they positively impacted quality and efficiency.
✨Demonstrate Strong Communication Skills
As excellent communication skills are essential for this role, practice articulating your thoughts clearly and confidently. Be prepared to explain complex concepts in simple terms, especially when discussing training activities or document control processes.