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- Tasks: Join our Quality team as a QMS Engineer, owning quality management and supporting compliance.
- Company: Be part of a well-established Medical Device manufacturer in Oxford, making a difference in healthcare.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Contribute to innovative projects while ensuring quality and compliance in medical devices.
- Qualifications: Experience in Quality Assurance and knowledge of ISO standards are essential.
- Other info: Engage in audits and training, enhancing your skills in a dynamic industry.
The predicted salary is between 36000 - 60000 £ per year.
GXPeople are looking for a QMS Engineer to join a well-established Medical Device manufacturer based in Oxford to join their Quality team.
About The Role
The Quality Management System (QMS) Engineer takes full ownership of the areas of Quality Management System. The role supports the rest of the QA/RA team and wider business with issues related to overall quality assurance, control and compliance.
Key Responsibilities
- Support quality driven technology driven projects.
- Development and update of QMS procedures and associated Work Instructions and documentation
- Compliance to ISO 13485:2016 and/ or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements
- Usage of Quality Investigational tools
- Not Analysis, Ishikawa, FMEA to identify the true root cause of an event.
- Manage, Maintain, and Implement CAPAs (Corrective and Preventative Actions)
- Development of flowcharts to improve QMS process understanding
- Continuously improving processes to promote more agile workflows
- Participation in the review and approval of processes
- Conduct gap analysis for standards and regulations
- Provide QMS Induction training for new starters
- Contribute to product Risk Assessment
- Plan and conduct internal and supplier audits, ideally as an ISO 13485:2016 Internal Auditor
- Co-host Notified Body, regulatory authority and customer audits (with QSM/SRAO)
- Plan and conduct Design History File and Device Master Record audits
- Experience in providing Quality Assurance support for New Product Development, Implementation and Launch
- Training of cross functional teams in using advanced quality planning tools, such as DFMEA, PFMEA, PPAP and others
- Support device testing activities (IEC 60601-1, 60601-1-2 etc)
- Assist in preparation of Technical Files
Experience
- Experience and working knowledge of Quality Assurance
- Experience in Medical Device Manufacturing
- Usage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event.
- Lead Auditor trained and certified
- Working knowledge of ISO 13485:2016, MDSAP, Medical Devices Directive (93/42/EEC) and Medical Devices Regulations (EU) MDR 2017/745
- Unique Device Identification (2013/172/EU)
- Knowledge of IEC 60601 standards, particularly 60601-1 (Electrical Safety), 60601-1-2 (EMC) and 60601-1-6 (Usability)
- Experience with Risk Management to ISO 14971
If you are looking for a new start in 2025 with a well-established business that have a great reputation in the market please apply to this advert or get in touch for more information.
Quality System Engineer employer: GxPeople Global
Contact Detail:
GxPeople Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality System Engineer
✨Tip Number 1
Familiarize yourself with ISO 13485:2016 and MDSAP requirements. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality management in the medical device industry.
✨Tip Number 2
Brush up on your knowledge of quality investigational tools like FMEA and Ishikawa diagrams. Being able to discuss how you've used these tools in past projects can set you apart from other candidates.
✨Tip Number 3
Prepare to discuss your experience with cross-functional training. Highlighting your ability to train teams on advanced quality planning tools will show that you can contribute to a collaborative work environment.
✨Tip Number 4
Be ready to share examples of how you've conducted gap analyses for standards and regulations. This practical experience is crucial for the role and will demonstrate your proactive approach to quality assurance.
We think you need these skills to ace Quality System Engineer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality System Engineer position. Understand the key responsibilities and required skills, especially those related to ISO 13485:2016 and quality investigational tools.
Tailor Your CV: Customize your CV to highlight relevant experience in Quality Assurance and Medical Device Manufacturing. Emphasize your familiarity with quality management systems and any specific tools mentioned in the job description, such as FMEA or Ishikawa.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the requirements of the role. Mention specific projects or experiences where you successfully implemented quality assurance processes or supported product development.
Highlight Continuous Improvement: In your application, showcase examples of how you've contributed to process improvements in previous roles. Discuss any initiatives you've led or participated in that align with the company's focus on agile workflows and compliance.
How to prepare for a job interview at GxPeople Global
✨Show Your Knowledge of QMS Standards
Make sure to demonstrate your understanding of ISO 13485:2016, MDSAP, and other relevant standards during the interview. Be prepared to discuss how you've applied these standards in previous roles and how they relate to the position you're applying for.
✨Discuss Quality Investigational Tools
Familiarize yourself with quality investigational tools like FMEA, Ishikawa, and the Five Whys Technique. Be ready to provide examples of how you've used these tools to identify root causes and improve processes in past projects.
✨Highlight Your Experience in Medical Device Manufacturing
Share specific experiences from your background in medical device manufacturing. Discuss any challenges you faced and how you overcame them, particularly in relation to quality assurance and compliance.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle quality-related issues. Practice articulating your thought process and decision-making steps when faced with hypothetical situations related to quality management.
