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- Tasks: Lead risk management activities and ensure compliance in the medical device industry.
- Company: Join Terumo Aortic, a leader in medical technology with a focus on quality.
- Benefits: Competitive salary, professional development, and a collaborative work environment.
- 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: Dynamic role with opportunities for growth and influence across functions.
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 (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) 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 Inchinnan 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 Inchinnan
✨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 FDA, ISO, and EU MDR regulations. We want you to be the go-to person for regulatory knowledge, so practice explaining complex concepts in simple terms. This will show your potential employer that you’re ready to hit the ground running!
✨Tip Number 3
Don’t just wait for job postings to come to you! Keep an eye on our website and apply directly through it. This way, you’ll be one step ahead and can tailor your application to what we’re looking for in a Senior Quality Engineer.
✨Tip Number 4
Showcase your problem-solving skills during interviews. Be ready to discuss specific examples where you've successfully managed risk or improved processes in a regulated environment. We love hearing about real-life experiences that demonstrate your expertise!
We think you need these skills to ace Senior Quality Engineer - Risk Management in Inchinnan
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 match 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 risk management and how your background makes you a perfect fit for our team. Keep it engaging and relevant to the job description.
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your expertise in quality assurance and risk management. Numbers and outcomes speak volumes, so don’t shy away from sharing your successes!
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 at StudySmarter!
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.
✨Prepare for Risk Management Scenarios
Think of specific examples from your past experience where you led risk management activities or handled Health Hazard Evaluations. Be ready to explain your thought process and how you ensured compliance while driving improvements.
✨Showcase Your Collaboration Skills
Since this role involves working across various functions, prepare to discuss how you've successfully collaborated with teams like Regulatory Affairs, Quality Control, and R&D. Highlight any challenges you faced and how you overcame them.
✨Demonstrate Analytical Thinking
Be prepared to tackle some analytical questions during the interview. You might be asked to assess a hypothetical risk scenario or evaluate a complaint. Practise articulating your problem-solving approach clearly and logically.
