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For Companies At a Glance
- Tasks: Lead risk management activities and ensure compliance in the medical device industry.
- Company: Join Terumo Aortic, a leader in medical technology with a commitment to quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety and regulatory compliance.
- Qualifications: Degree in Science/Engineering and experience in medical device regulations required.
- Other info: Collaborative environment with opportunities for continuous learning and development.
The predicted salary is between 36000 - 60000 £ per year.
Are you an experienced quality professional with a passion for risk management and regulatory compliance in the medical device industry? Terumo Aortic is seeking a Senior Quality Engineer – Risk Management to join our Quality Assurance team.
Key Responsibilities
- Lead and coordinate all risk management activities, including Health Hazard Evaluations (HHEs), Field Safety Corrective Actions (FSCAs), and Field Safety Notices (FSNs).
- Ensure country-specific regulations and standards are incorporated into risk management activities.
- Provide input into complaints, change control, and CAPA processes, ensuring customer feedback is used for continuous improvement.
- Act as a primary source of regulatory knowledge within QA, supporting agile decision‑making and regulatory affairs input.
- Present status updates and KPIs to senior management, ensuring timely risk assessments and field actions.
- Collaborate across functions (Regulatory Affairs, Clinical, Quality Control, Operations, R&D, Engineering, Commercial) to ensure smooth completion of activities.
- Support post‑market surveillance and maintain global market access.
- Conduct internal audits and support external audits as a subject matter expert (e.g., FDA inspections, Notified Body audits).
- Provide training and guidance on risk management regulations and standards.
What We’re Looking For
- Degree in Science/Engineering or equivalent background.
- In-depth knowledge of medical device regulations and standards (FDA, ISO, EU MDR).
- Experience with risk management and field management activities in a regulated environment.
- Strong analytical, problem‑solving, and communication skills.
- Certification such as CQE, CQA, or Lead Auditor (ISO 13485) is highly desirable.
- Experience with QMS tools and document control systems.
- Ability to work independently and influence change at all levels.
- Competence in IT technology (Microsoft Office and QA systems).
Senior Quality Engineer - Risk Management in Scotland employer: Terumo Aortic
Contact Detail:
Terumo Aortic Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Engineer - Risk Management in Scotland
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Senior Quality Engineer role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of risk management regulations and standards. Be ready to discuss how you've tackled similar challenges in the past, especially in relation to FDA and ISO compliance. We want to see your expertise shine!
✨Tip Number 3
Showcase your analytical and problem-solving skills during interviews. Bring examples of how you've used these skills in previous roles, particularly in risk management activities. This will help us see how you can contribute to our Quality Assurance team.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us that you're genuinely interested in joining our team at Terumo Aortic.
We think you need these skills to ace Senior Quality Engineer - Risk Management in Scotland
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Quality Engineer role. Highlight your experience in risk management and regulatory compliance, especially in the medical device industry. We want to see how your skills align 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 risk management and how your background makes you a perfect fit for our team. We love hearing personal stories that connect to the role.
Showcase Your Achievements: When detailing your experience, focus on specific achievements related to risk management activities. Whether it's leading audits or improving processes, we want to know how you've made an impact in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Terumo Aortic
✨Know Your Regulations
Make sure you brush up on the key medical device regulations and standards like FDA, ISO, and EU MDR. Being able to discuss these confidently will show that you’re not just familiar with them but can also apply them in real-world scenarios.
✨Showcase Your Risk Management Experience
Prepare specific examples of your past experiences with risk management activities, such as Health Hazard Evaluations or Field Safety Corrective Actions. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your impact.
✨Collaborate Like a Pro
Since the role involves working across various functions, be ready to discuss how you've successfully collaborated with teams in the past. Think of instances where your communication skills helped bridge gaps between departments, especially in quality assurance.
✨Prepare for Technical Questions
Expect some technical questions related to Quality Management Systems and document control tools. Brush up on your knowledge of QMS tools and be prepared to explain how you’ve used them to improve processes in your previous roles.
