At a Glance
- Tasks: Support and maintain key Quality Management System processes in a regulated environment.
- Company: Join a leading medical device organisation focused on quality and innovation.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Collaborative culture with opportunities for professional development.
- Why this job: Take ownership of critical QMS activities and drive quality improvements.
- Qualifications: Experience in regulated environments and strong understanding of ISO 13485.
The predicted salary is between 35000 - 45000 € per year.
A medical device / life sciences organisation is seeking a Quality Systems Engineer to support and maintain key Quality Management System (QMS) processes within a regulated environment. This role will take ownership of core quality processes including:
- Document Control
- Change Control
- Failure Investigations / Root Cause Analysis
The position works closely with cross-functional teams including Production, Engineering, Regulatory Affairs, R&D, and Supply Chain to ensure compliance with ISO 13485 and FDA quality standards. The successful individual will play a key role in maintaining accurate documentation, supporting audits, driving quality improvements, and ensuring robust investigation processes across manufacturing and operational activities.
Key Responsibilities
- Manage document control activities across the full document lifecycle
- Maintain and administer electronic document management systems (eDMS/eQMS)
- Coordinate and facilitate change control processes and assessments
- Lead product and process failure investigations using structured RCA methodologies (5-Why, Fishbone, FMEA, 8D etc.)
- Support external audits and regulatory inspections
- Promote a quality-focused culture across the organisation
- Collaborate with multiple departments to ensure compliance and process improvement initiatives are delivered effectively
Ideal Background
- Experience within medical device, IVD, pharmaceutical, or highly regulated environments
- Strong understanding of ISO 13485, GMP, and/or 21 CFR Part 820
- Experience with document management systems and quality systems processes
- Ability to manage investigations, documentation, and cross-functional activities independently
- Strong communication and organisational skills
Desirable Experience
- Internal auditing experience
- Lean / Six Sigma exposure
- Risk management and validation knowledge
- Experience supporting regulatory inspections and technical documentation
This opportunity would suit someone looking to take ownership of critical QMS activities within a growing and quality-focused environment.
Quality Systems Engineer in Edinburgh employer: Kinara Group
Join a leading medical device organisation that prioritises quality and compliance, offering a collaborative work culture where your contributions directly impact patient safety and product excellence. With a strong focus on employee development, you will have access to continuous training and growth opportunities while working alongside dedicated professionals in a dynamic environment that values innovation and quality improvement.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Systems Engineer in Edinburgh
✨Tip Number 1
Network like a pro! Reach out to folks in the medical device and life sciences sectors. Attend industry events or webinars, and don’t be shy about connecting on LinkedIn. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of ISO 13485 and FDA standards. We recommend having specific examples ready that showcase your experience with document control and failure investigations. Show them you’re the quality systems guru they need!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds. We believe a little courtesy can make a big difference.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to navigate. Let’s get you that Quality Systems Engineer role!
We think you need these skills to ace Quality Systems Engineer in Edinburgh
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Systems Engineer role. Highlight your experience with QMS processes, document control, and any relevant regulatory knowledge. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality systems in the medical device field. Share specific examples of how you've contributed to quality improvements or compliance in past roles.
Showcase Your Skills:Don’t forget to showcase your skills in structured RCA methodologies and document management systems. We love seeing candidates who can demonstrate their problem-solving abilities and attention to detail in their applications.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status directly with us!
How to prepare for a job interview at Kinara Group
✨Know Your Quality Standards
Make sure you brush up on ISO 13485 and FDA quality standards before the interview. Being able to discuss these regulations confidently will show that you understand the importance of compliance in a regulated environment.
✨Prepare for Technical Questions
Expect questions about document control, change control, and failure investigations. Familiarise yourself with methodologies like 5-Why and Fishbone diagrams so you can demonstrate your problem-solving skills effectively.
✨Showcase Your Cross-Functional Experience
Since this role involves collaboration with various departments, be ready to share examples of how you've worked with teams like Production, Engineering, or Regulatory Affairs. Highlighting your teamwork skills will make you stand out.
✨Emphasise Your Quality Improvement Mindset
Talk about any initiatives you've led or been part of that focused on quality improvements. This could include process enhancements or successful audits. Showing your commitment to a quality-focused culture is key!
