At a Glance
- Tasks: Support and maintain key Quality Management System processes in a regulated environment.
- Company: A leading medical device and life sciences organisation focused on quality.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Collaborate with diverse teams and promote a quality-focused culture.
- Why this job: Take ownership of critical quality processes and drive improvements in a dynamic setting.
- Qualifications: Experience in regulated environments and strong understanding of quality systems.
The predicted salary is between 40000 - 50000 € 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
- Internal auditing experience
- 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 employer: Kinara Group
Join a leading medical device and life sciences organisation that prioritises quality and compliance in a dynamic and collaborative work environment. As a Quality Systems Engineer, you will benefit from a culture that fosters professional growth, with opportunities to engage in cross-functional projects and drive meaningful improvements in quality management systems. Located in a thriving area, the company offers competitive benefits and a commitment to employee development, making it an excellent choice for those seeking a rewarding career in a regulated industry.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Systems Engineer
✨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 champion 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 gratitude can make a big impact.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly helps us keep track of your application. Plus, it shows you’re serious about joining our quality-focused team!
We think you need these skills to ace Quality Systems Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Systems Engineer role. Highlight your experience with ISO 13485 and any relevant quality management systems. We want to see how your background fits perfectly with what we're looking for!
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 in past roles, and let us know why you want to join StudySmarter.
Showcase Your Skills:Don’t forget to showcase your skills in document control and failure investigations. Mention any structured RCA methodologies you’ve used, like 5-Why or Fishbone. We love seeing candidates who can demonstrate their expertise in these areas!
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
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 Scenario Questions
Expect questions about how you've handled document control, change control, or failure investigations in the past. Prepare specific examples using structured methodologies like 5-Why or Fishbone to demonstrate your problem-solving skills.
✨Show Your Collaborative Spirit
Since this role involves working with cross-functional teams, be ready to talk about your experience collaborating with different departments. Highlight any successful projects where you facilitated communication and drove quality improvements.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to quality culture or how they handle audits. This shows your genuine interest in the role and helps you assess if it’s the right fit for you.
